Recall Z-2136-2008 ยท LMC Camera, Multi Format, Radiological
AGFA Corp.
Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
| Date | Sep 18, 2008 (initiated May 16, 2008) |
| Status | Terminated |
| Reason | The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON". |
| Root cause | Other |
| Action | Consignees were notified by an Urgent Safety Notice letter on/about 05/16/2008. The letter provides the procedure the customer can follow to change the film calibration setting from "OFF" to "ON". The letter also provides information on how to get assistance from Agfa, if the customers prefer a service engineer perform the change. Consignees were instructed to send a copy of the letter or similar letter to their affected accounts. Agfa also offers to dispatch a service engineer to perform the parameter change. |
| Quantity | 33 units |
| Distribution | Worldwide Distribution --- USA including states of DE, FL, IL, KS, MA, MD, ME, MO, MT, NJ, NY, OH, OK, TX, UT, VA, WA, WV, and Puerto Rico and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072680 | DRYSTAR AXYS, MODEL EYZ4E Agfa Healthcare Corporation, Oct 25, 2007 |