Recall Z-1306-04 ยท KPR System, X-Ray, Stationary
Philips Medical Systems Sales & Service Region No. America
EasyDiagnost Eleva Part Number 989605071921
| Date | Aug 4, 2004 (initiated Jun 8, 2004) |
| Status | Terminated |
| Reason | When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination. |
| Root cause | Other |
| Action | The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2. |
| Quantity | 46 |
| Distribution | Philips Medical Systems North American Company distributes product to medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.