Recall Z-0353-06 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
| Date | Jan 6, 2006 (initiated Nov 18, 2005) |
| Status | Terminated |
| Reason | Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis. |
| Root cause | Other |
| Action | Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software. |
| Quantity | 2630 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010571 | ADC QS/IPD WORKSTATION Agfa Corp., Mar 28, 2001 |