PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Recommended Action

Per FDA guidance

Philips issued Urgent Medical Device Correction (UMDC) letter US customers in the US on 11/3/23 and a Field Safety Notice (FSN) to customers outside the US. Letter states reason for recall, health risk and action to take: As a remedy, Philips is replacing the existing covers of all the affected Philips Allura and Philips Azurion with the monoplane fixed ceiling mounted systems with a redesigned L-arm rotation cover (bolted instead of spring clips) to make sure it is resistant to external collisions. Philips will contact all affected customers to arrange for a Field Service Engineer visit to replace the Larm rotation cover free of charge (reference FCO72200510 for the Philips Allura systems including the Philips Poly G H5000, FCO72200511 for the Philips Azurion systems). If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).