Recall Z-2307-2016 ยท IZI System, X-Ray, Angiographic
Philips Electronics North America Corporation
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
| Date | Jul 19, 2016 |
| Status | Terminated |
| Reason | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag |
| Root cause | Device Design |
| Action | On July 19, 2016, Philips sent a Field Safety Notice to all affected customers. Philips Field Service Engineers will add an independent safety catch free of charge. |
| Quantity | 993 total |
| Distribution | Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023441 | PHILIPS MULTIDIAGNOST ELEVA Philips Medical Systems, Oct 30, 2002 |