Recall Z-0558-2024 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023 Allura Xper FD20 OR Table 722026 Allura Xper FD10 722028 Allura Xper FD20 722033 All
| Date | Dec 15, 2023 (initiated Nov 3, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 9991 units |
| Distribution | Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Rep |
| FDA record | Open on fda.gov |