Z-2136-2008

Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography...

Name: Z-2136-2008 Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography...
Creator: AGFA Corp.
Published: 2008-05-16
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2008-05-16 / Terminated / root cause: manufacturing process

FDA source

AGFA Corp. began a recall of Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a... on 2008-05-16. The reason FDA records is "The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2136-2008
Status: Terminated
Initiated: 2008-05-16
Posted: 2008-09-18
Terminated: 2008-10-10
Recalling firm: AGFA Healthcare 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.
Product code: LMC Camera, Multi Format, Radiological
Reason for recall: The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and 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.

Product code LMC

K072680Class IIDrystar Axys, Model Eyz4eAgfa Healthcare Corporation / cleared 2007-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)