Recall Z-1077-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
| Date | Feb 4, 2025 (initiated Jan 13, 2025) |
| Status | Open, Classified |
| Reason | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel |
| Root cause | Device Design |
| Action | Philips issued URGENT Medical Device Correction Letter via Certified Mail (USPS) on 1/13/25. Letter states reason for recall, health risk and action to take: " Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. " Follow the additional instructions when positioning the patient table included in Appendix B. These instructions include information of potential finger entrapment areas when moving the table. The information of this Appendix is being included in an Addendum to the Instructions for Use. Additionally, Philips is cr |
| Quantity | 474 units US; 1908 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, Chin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031333 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 Philips Medical Systems North America, Inc., May 13, 2003 |
| K041949 | ALLURA XPER FD10 Philips Medical Systems North America Co., Jul 30, 2004 |
| K162859 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Dec 2, 2016 |