Recall Z-1160-2025 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
| Date | Feb 20, 2025 (initiated Jan 13, 2025) |
| Status | Open, Classified |
| Reason | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Root cause | Under Investigation by firm |
| Action | On January 14, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users " 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 on the use of the mattress included in Appendix B. These instructions include information for the transfer of the patient and the correct use and positioning of the mattress. The information of this Appendix is being included in an Addendum to the Instru |
| Quantity | 4,221 units (1480 US, 2741 OUS) |
| Distribution | Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033737 | ALLURA XPER FD20 Philips Medical Systems North America, Inc., Dec 9, 2003 |
| K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES Philips Medical Systems Nederland B.V., May 21, 2013 |
| K163715 | Allura Xper R9 Philips Medical Systems Nederland B.V., Jan 26, 2017 |
| K172822 | Azurion series R1.2 Philips Medical Systems Nederland B.V., Nov 22, 2017 |
| K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., May 1, 2020 |