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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
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.
Products Sold
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.
AGFA Corp. is recalling Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mam due to The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
DE, FL, IL, KS, ME, MD, MA, MO, MT, NJ, NY, OH, OK, TX, UT, VA, WA, WV, PR
Page updated: Jan 10, 2026