Warning
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recalls Philips Azurion
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2170-2026Medical Device
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recalls Philips Azurion
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II — Moderate Risk
Product Description
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).
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. initiated the recall on March 31, 2026 affecting 1,718 units. 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. The product was distributed internationally, including the United States. Consumers should check their purchases and discontinue use of any affected product. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.