Recall Z-0352-06 ยท KPR System, X-Ray, Stationary
AGFA Corp.
ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.
| Date | Jan 6, 2006 (initiated Nov 18, 2005) |
| Status | Terminated |
| Reason | Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis. |
| Root cause | Other |
| Action | Consignees were notified by letter on/about December 1, 2005. |
| Quantity | 1059 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974597 | ADC COMPACT (AGFA DIAGNOSTIC CENTER) Bayer Corp., Agfa Div., Mar 9, 1998 |