FDA recall, , Moderate risk
Philips Azurion
Philips Azurion has bolts and plastic parts that may loosen or break.
Summary by Recall Canary from the FDA notice
What happened
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. of Best, Netherlands is recalling the Philips Azurion because the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated. The recall affects 1,718 units nationwide in the US and in Canada. The company began the recall on March 31, 2026, and the FDA added it to the Enforcement Report on May 12, 2026.
The recalled products include the Azurion 3 M12, Azurion 3 M15, Azurion 5, Azurion 5 M12, Azurion 5 M20, Azurion 7, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, and Azurion 7 M20 models. The agency stated that the potential for the bolts and plastic parts may loosen and/or break.
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?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
- UDI-DI
- 00884838099203
- 00884838116726
- 00884838099210
- 00884838116733
- 00884838110564
- 00884838099227
- 00884838116740
- 00884838099234
- 00884838116757
- 00884838110571
- 00884838099265
- 00884838116788
- 00884838085367
- 00884838099272
- 00884838116801
- 00884838085251
- 00884838099241
- 00884838116764
- 00884838099258
- 008848380992
- 00884838116771
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Canada.
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- 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
- 98748
- Recall number
- Z-2170-2026
- Quantity recalled
- 1,718 units
All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
In FDA's weekly enforcement report
Summary updated
