FDA recall, , Moderate risk
Philips North America Model 712010
The device can fail immediately after an exposure, causing the system to remain stationary.
Summary by Recall Canary from the FDA notice
What happened
Philips North America began a recall on September 18, 2026, for Model Number 712010 because the device can fail immediately after an exposure, causing the system to remain stationary. The recall was added to the FDA's Enforcement Report and classified on October 26, 2026.
The product was distributed nationwide in the US and internationally 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
Incomplete list: 40 of 564 UDI-DIs shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Model Number: 712010.
- UDI-DI
- 00884838115521
- 26000155
- 26000154
- 26000151
- 26000150
- 26000149
- 26000148
- 26000147
- 26000146
- 26000145
- 26000144
- 26000143
- 26000142
- 26000141
- 26000140
- 26000139
- 26000138
- 26000137
- 26000136
- 26000135
- 26000134
- 26000133
- 26000132
- 26000129
- 26000125
- 26000126
- 26000131
- 26000130
- 26000124
- 26000123
- 26000122
- 26000121
- 26000120
- 26000119
- 26000118
- 26000116
- 26000115
- 26000113
- 26000110
- 26000109
712010
Recall details
- Company began the recall
- Sold in
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.
- Company
- Philips North America
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 100074
- Recall number
- Z-0288-2027
- Quantity recalled
- 563 units
All recalls from Philips North America
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
