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).
FDA Recall Z-2170-2026 · Posted 2026-05-12
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Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2026-03-31
Product Quantity1,718 units
Reason for Recall
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.
Firm Action
Philips notified consignees on about 03/31/2026 via "URGENT Medical Device Correction" letter. Consignees were instructed to circulate the letter to all users of the system so that they are aware of the issue and follow the instructions, maintain the notification with the documentation of the system until Philips corrects the system, and notify consignees/facilities in case the affected system has been transferred. Consignees were also requested to complete and return the provided response form to Philips.
Philips is starting installation of the redesigned Cable Hose Carrier assembly on the affected systems. A Philips service representative will contact consignees to schedule implementation of the correction.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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