FDA-Device2026-10-26Class IIPROCESSING DEFECT
Philips North America Model 712010 device recalled for potential failure risk
What this means
Philips North America has recalled Model 712010 devices due to a potential for the device to fail immediately after exposure, which could cause the system to stop working. Approximately 563 units are affected.
- Check if you own a Philips Model 712010 device
- Contact Philips North America for instructions on how to proceed
- Do not use the device if you believe it may be affected
The agency's original wording
Hazard
Potential for the device to fail immediately after an exposure, causing the system to remain stationary.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
563 units
Manufactured in
222 Jacobs St, Cambridge, Massachusetts, United States
Products
Model Number: 712010.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2027More Philips recalls
- FDA-Device2026-10-16Philips Smart-hopping 2.0 AP wireless access point recalled for connectivity loss risk
- FDA-Device2026-10-07Philips SmartPath MRI software recalled for incorrect DTI export data
- FDA-Device2026-10-07Philips MR 7700 MRI system recalled for incorrect DTI export data in Enhanced DICOM format
- FDA-Device2026-10-07Philips Ingenia Elition MRI systems recalled for incorrect DTI scan exports
- FDA-Device2026-10-07Philips Ingenia Ambition MRI systems recalled for incorrect brain imaging data export
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