Recall Ledger

Philips PIC iX Essentials REF:867093 recall (Philips North America)

Medical deviceClass IIOngoing

Summary: Philips North America is recalling Philips PIC iX Essentials REF:867093. Reason: Due to software malfunction, patient information system may freeze and become unresponsive.

What is being recalled

Philips PIC iX Essentials REF:867093

Why

Due to software malfunction, patient information system may freeze and become unresponsive.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Andorra, Utd. Arab. Emir., Argentina, Austria, Australia, Aruba, Bosnia-Herz., Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep, Algeria, Estonia, Spain, Finland, Fiji, Faroe Islands, France, United Kingdom, Gibraltar, Guadeloupe, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon , Sri Lanka, Lithuania, Luxembourg, Latvia, Libya, Morocco, Monaco, Montenegro, Macedonia, Macao, Martinique, Maldives, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Puerto Rico, Portugal, Qatar R¿union, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Turkmenistan, Tunisia, T¿rkiye, Taiwan, Ukraine, Uzbekistan, Vietnam, South Africa. (states named: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming)

How to tell if yours is affected

All PIC iX software versions 4.0-4.5/UDI: (01)00884838122772

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3142-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 31, 2026
ReportedSeptember 23, 2026
CompanyPhilips North America
Company locationCambridge, MA, United States
Initiated byVoluntary: Firm initiated
Quantity312 units

More recalls from Philips North America · all medical device recalls · recalls from July 2026

Official FDA record