Recall Z-1904-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Medical Systems Nederlands
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
| Date | Jun 23, 2016 |
| Status | Terminated |
| Reason | Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering. |
| Root cause | Component design/selection |
| Action | On April 23, 2021, Philips Healthcare issued an Urgent Medical Device Correction notice to customers via letter notifying them that Philips Healthcare has discovered through trend analysis an increase in the failure rate of certain low-voltage DC power supplies (DCPS) used in these products. Each system contains multiple DCPS, some of which may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering. HOW TO IDENTIFY AFFECTED PRODUCTS: For systems menti |
| Quantity | 42 devices |
| Distribution | Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico. |
| 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 |