Model Number: 712010. recall (Philips North America)
Medical deviceClass IIOngoing
Summary: Philips North America is recalling Model Number: 712010.. Reason: Potential for the device to fail immediately after an exposure, causing the system to remain stationary.
What is being recalled
Model Number: 712010.
Why
Potential for the device to fail immediately after an exposure, causing the system to remain stationary.
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 Distribution: (US Nationwide) and International distribution to Angola, Australia, Austria, Canada, Chile, Cook Islands, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Honduras, Israel, Italy, Latvia, Lithuania, Macedonia, Namibia, Netherlands, New Zealand, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom.
How to tell if yours is affected
Model Number: 712010. 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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 number | Z-0288-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 18, 2026 |
| Reported | November 4, 2026 |
| Company | Philips North America |
| Company location | Cambridge, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 563 units |
More recalls from Philips North America · all medical device recalls · recalls from September 2026