Recall Z-2160-2008 ยท IZJ Camera, X-Ray, Fluorographic, Cine Or Spot
Philips Medical Systems North America Co. Phillips
General X-Ray System types with Digital Spot Imaging (DSI) software
| Date | Aug 25, 2008 (initiated May 23, 2008) |
| Status | Terminated |
| Reason | X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted). |
| Root cause | Software design |
| Action | On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June. |
| Quantity | 41 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920793 | PHILIPS DSI SYSTEM RELEASE 3.2 Philips Medical Systems, Inc., Jul 17, 1992 |