Recall Z-1128-03 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems
EasyWeb
| Date | Aug 12, 2003 (initiated Feb 13, 2002) |
| Status | Terminated |
| Reason | Potential for incorrect body part information |
| Root cause | Other |
| Action | A letter dated 2/13/02 was issued to customers advising that a representative from the firm will install new software. |
| Quantity | 28 |
| Distribution | The firm distributed units to hospitals and medical centers located throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982769 | MITRA IMAGING INC. EXHIBIT Mitra Imaging, Inc., Nov 3, 1998 |