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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 03, 2005
Date Posted May 09, 2006
Recall Status1 Terminated 3 on June 20, 2006
Recall Number Z-0855-06
Recall Event ID 34776
510(K)Number K050810  
Product Classification computed radiography system digitizer - Product Code MQB
Product CR DX-S, DX-S, Computed radiography system (Digitizer)
Code Information CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B and below.
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
864-421-1827
Manufacturer Reason
for Recall		 Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
FDA Determined
Cause 2		 Other
Action Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.
Quantity in Commerce 3 units
Distribution DC, MS, OR--three states
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 = MQB and Original Applicant = AGFA CORP.
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