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U.S. Department of Health and Human Services

Class 3 Device Recall Drystar AXYS

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  Class 3 Device Recall Drystar AXYS see related information
Date Initiated by Firm May 16, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on October 10, 2008
Recall Number Z-2136-2008
Recall Event ID 48462
510(K)Number K072680  
Product Classification Multi Format Radiological Camera - Product Code LMC
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.
Code Information 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.
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
Manufacturer Reason
for Recall
The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LMC and Original Applicant = AGFA HEALTHCARE CORPORATION