Recall Z-1487-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America, LLC
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
| Date | Dec 30, 2019 |
| Status | Terminated |
| Reason | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible. |
| Root cause | Component design/selection |
| Action | On December 30, 2019, the firm notified customers via Medical Device Correction letter. Customers were informed of the product issue and advised to do the following: If the capacitor of the Velara X-Ray fails as described (capacitor failure after large number of surges in a short period of time), please switch off the system, take it out of service immediately, and contact your local Philips representative. The firm will be resolving the issue by replacing a Printed Circuit Board (PCB) in the convertor, which prevents the capacitor from failing. PCB replacements started in January 2020. Cust |
| Quantity | 70 |
| Distribution | Nationwide domestic distribution. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002016 | PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc., Sep 6, 2000 |