Recalls in Maine (page 35)
3867 recalls.
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V ... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Vivoo Sodium Test recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - Vivoo Vaginal pH Test recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - Vivoo Protein Test recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - Vivoo pH Test recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - Exploro Highly Sensitive Male Fertility / Sperm Concentration Test recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - Male Fertility Sperm Test for Home Use recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - S. Typhi/Para Typhi A Antigen recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - Menopause Test Cassette recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - LH One Step Ovulation Test Device recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - LotFancy Urinary Tract Infection Urine recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIReported February 11, 2026 · Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers... - Vortex Surgical Lindsell Sutured IOL Marker recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 25GA Backflush recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical TID Pharos Illuminated Depressor recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · XXX - Rumex Disposable Diamond Dusted ILM Elevator recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical I2 Injection Kit recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Tecfen Retractable Membrane Polisher recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 25GA I.D.D. Internal Delivery Device recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - 25GA Subretinal Injection Cannula VS0220.25 recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 ... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser... recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens recall (Vortex Surgical Inc.)
Medical deviceClass IIReported February 11, 2026 · There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of... - Focalyx Fusion recall (Focalyx Technologies, LLC.)
Medical deviceClass IIReported February 11, 2026 · Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function... - NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT... recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported February 11, 2026 · To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. - TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE recall (Tornier, Inc)
Medical deviceClass IIReported February 11, 2026 · A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery... - VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B recall (Biomerieux Inc)
Medical deviceClass IIReported February 11, 2026 · Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species... - CellMek SPS Sample Preparation System recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported February 11, 2026 · Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching... - PRISMAFLEX TPE2000 SET recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - PRISMAFLEX HF1000 SET recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - PRISMAFLEX HF1000 SET recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - PRISMAFLEX M150 SET recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - PRIMSAFLEX M100 SET recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - OXIRIS SET recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - PRISMAFLEX ST150 SET US recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - PRISMAFLEX ST100 SET US recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIReported February 11, 2026 · There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - Andy & Evan Recalls Children's Pajama Sets Due to Risk of Serious Injury or Death from Burn Hazard; Violate Mandatory Standard for Children's Sleepwear
Consumer productReported February 6, 2026 · The recalled children's pajamas violate the mandatory flammability standard for children's sleepwear, posing a risk of serious burn injuries or death. - EnHomee 10-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units
Consumer productReported February 6, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Cobelae Busy Books Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Violates Small Parts Ban; Sold on Amazon by Flyindream
Consumer productReported February 6, 2026 · The toy books violate the small parts ban because the beads can loosen and detach from the product, posing a deadly choking hazard. - Clark Associates Recalls Lancaster Table & Seating Powder-Coated Aluminum Outdoor Restaurant Chairs and Barstools Due to Fall Hazard
Consumer productReported February 6, 2026 · The legs of the chairs and barstools can bend or break while the chair is in use, posing a fall hazard. - Scepter Fuel Containers Recalled Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for Portable Fuel Containers; Imported by Mameix Retail
Consumer productReported February 6, 2026 · The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the... - YITA Recalls Multiple Brands of Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units
Consumer productReported February 6, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Aterian Recalls PurSteam Elite Travel Steamers and Mighty Lil Steamers Due to Risk of Serious Burn Injury
Consumer productReported February 6, 2026 · The steamers can expel hot water from the steam nozzle during use, posing a serious burn hazard to consumers. - Dresbe LED Christmas Headbands Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries
Consumer productReported February 6, 2026 · The recalled headbands violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries in the... - Fixwal 7-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units
Consumer productReported February 6, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Furnulem 5-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units
Consumer productReported February 6, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Kitosun Submersible LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries
Consumer productReported February 6, 2026 · The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin... - GM Gumili Wintergreen Essential Oil Bottles Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Gumili Beauty
Consumer productReported February 6, 2026 · The essential oil contains methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The... - Organic Zing Birch Essential Oil Bottles Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Linkers
Consumer productReported February 6, 2026 · The essential oil bottles contain methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The... - Little Cow Company Recalls 9 oz Candles in Glass Jars Due to Fire, Burn and Laceration Hazards
Consumer productReported February 6, 2026 · The glass jar holding the candle can crack or break during use, posing fire, burn and laceration hazards. - Lola Plus The Boys Recalls Youth Clothing with Drawstrings Due to Risk of Serious Injury or Death from Strangulation Hazard; Violates Federal Rule for Children's Upper Outerwear
Consumer productReported February 6, 2026 · The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to the strangulation hazard. The clothes... - Semfri Children's Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets
Consumer productReported February 6, 2026 · The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, positional... - Shintenchi 6-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported February 6, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - Zan International Trading Recalls Lotus Joy Sweet Birch Essential Oil Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
Consumer productReported February 6, 2026 · The essential oil bottles contain methyl salicylate, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The... - Hannaford hamburger dill pickle chips 16 FL OZ recall (Mount Olive Pickle Company, Inc.)
FoodClass IIReported February 4, 2026 · Glass in Pickles. The firm received complaints of glass found in the product. - BEAR Implant. Model Number: 1000. recall (Miach Orthopaedics)
Medical deviceClass IIReported February 4, 2026 · Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be... - SmartPath to dStream for XR and 3.0T. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - SmartPath to dStream for 3.0T. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Upgrade to MR 7700. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - MR 7700. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Ingenia Elition X. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Ingenia Elition S. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Ingenia Ambition X. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Ingenia Ambition S. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Ingenia 3.0T CX. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Ingenia 3.0T. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Ingenia 1.5T. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Evolution Upgrade 3.0T. Product Code recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Evolution Upgrade 1.5T. Product Codes recall (Philips North America)
Medical deviceClass IIReported February 4, 2026 · The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).