Recall Z-0973-04 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems Sales & Service Region No. America
Xcelera System, image processing, radiological.
| Date | Jul 20, 2004 (initiated Apr 15, 2004) |
| Status | Terminated |
| Reason | Potential for the image data to be erased from the long term archive. |
| Root cause | Other |
| Action | On 4/15/04 the firm sent letters to customers advising of the problem and that a service representative will visit and conduct a software upgrade. |
| Quantity | 56 units |
| Distribution | Devices were distributed to hospitals and medical centers throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022788 | PHILIPS HARMONY RELEASE 1 Philips Medical Systems North America Co., Oct 25, 2002 |