Recall Z-2156-2012 ยท KPR System, X-Ray, Stationary
Philips Healthcare Inc.
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
| Date | Aug 8, 2012 (initiated Jul 11, 2012) |
| Status | Terminated |
| Reason | When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. |
| Root cause | Software design |
| Action | Philips issued an Urgent Field Safety Notice dated July 2, 2012 to all affected customers. The letter identified the affected product, problem description, actions to be taken by the customer/user in order to prevent risks for patients or users and actions planned by Philips to correct the problem. For question or support concerning this issue contact your local Philips representative. |
| Quantity | 41 units |
| Distribution | Worldwide Distribution - US (nationwide) including the states of CA, CT, MI, MN, MN, NC, NY, NY, VA and the countries of Belgium, Columbia, Czech Republic and Denmark. France Germany Italy Latvia Luxembourg Netherlands Russian Fed. Spain Sweden Switzerland Thailand United Kingdom |
| 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 |