Recall Z-2587-2023 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
| Date | Sep 14, 2023 (initiated Aug 15, 2023) |
| Status | Open, Classified |
| Reason | A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible. |
| Root cause | Device Design |
| Action | US customers were notified via certified mail via USPS. OUS customers were notified through the Philips Markets Organizations. Philips is issuing two Urgent Medical Device Correction letters, one for Allura and Azurion customers and another one for MultiDiagnost Eleva Customers. Additionally, an IFU addendum will be provided to customers that includes instructions on how to handle the footswitch cable. For Allura and Azurion customers an updated preventative maintenance manual update is also being provided. Philips will contact customers to schedule a visit to inspect the foot switch and to |
| Quantity | 19,115 systems |
| Distribution | Worldwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050151 | MULTIDIAGNOST ELEVA Philips Medical Systems North America, Inc., Feb 9, 2005 |
| K162859 | Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland B.V., Dec 2, 2016 |
| K163715 | Allura Xper R9 Philips Medical Systems Nederland B.V., Jan 26, 2017 |
| K200917 | Azurion R2.1 Philips Medical Systems Nederland B.V., May 1, 2020 |