FDA-Device2026-05-20Class IIPROCESSING DEFECT
Philips Azurion imaging systems recalled for cable hose carrier failure risk
What this means
Bolts and plastic parts on the Cable Hose Carriers that attach cable hoses to the monitor ceiling suspension may loosen or break over time when the monitor is moved or rotated. This affects multiple Azurion 3, 5, and 7 model variants.
- Check your Azurion system's model number and UDI against the recall list
- Contact Philips Medical Systems for instructions on inspection or replacement of affected Cable Hose Carriers
- Do not operate the system if cable hose carriers appear loose or damaged
The agency's original wording
Hazard
Potential for 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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
1,718 units
Manufactured in
Veenpluis 6, Best, Netherlands
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2170-2026Want us to check the next one for you?
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