Recall Z-2136-2008
AGFA Corp. · initiated May 16, 2008
Product
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.
Codes / lots: ID number EYZ4E, Serial numbers: 1024 to 1189; but excluding 1053, 1057, 1089, 1096, 1097, 1098, 1101, 1103, 1161, 1166, 1173, 1176, 1177, 1178, 1180, 1181, 1185, 1186, 1187 and 1188.
Reason for recall
The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2136-2008
- Initiated
- May 16, 2008
- Posted by FDA
- September 18, 2008
- Terminated
- October 10, 2008
- Product code
- LMC – Camera, Multi Format, Radiological
- 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.
- Recalling firm
- AGFA Corp., Greenville, SC