FDA Medical Device Recalls (openFDA)
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 number
- Z-2136-2008
- Recalling firm
- AGFA Corp.
- 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.
- Status
- Terminated
- Initiated
- 2008-05-16
- Posted
- 2008-09-18
- Terminated
- 2008-10-10
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K072680"]
- PMA numbers
- not on file
- Product code
- LMC
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28