Recall Z-2475-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America Llc
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis." "Cardiac imaging applications including
| Date | Aug 13, 2021 |
| Status | Terminated |
| Reason | Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced. |
| Root cause | Device Design |
| Action | Philips notified accounts by Urgent Medical Device Recall letter via certified mailing United States Postal Service (USPS) on 8/13/21. Letter states reason for recall, health risk and action to take: Please place this Medical Device Recall letter with the documentation of the system until this correction has been implemented in your system. Additionally, please return the attached reply form to Phhilps to confirm that the users of the system have reviewed and understood this Medical Device Recall. Philips will correct the affected systems by replacing the ADUs. A Philips service representat |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the states of ID, MA, MI, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141979 | ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV, Aug 19, 2014 |