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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX 6.2.1

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 Class 2 Recall
IMPAX 6.2.1
see related information
Date Posted September 11, 2008
Recall Status1 Open
Recall Number Z-1245-2008
Recall Event ID 46386
Premarket Notification
510(K) Numbers
K022292  K040555  K050751 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX® 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
Code Information Software version IMPAX 6.2.1
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
864-421-1815
Manufacturer Reason
for Recall
Text and Images may not be synchronized.
FDA Determined
Cause 2
DESIGN: Software Design
Action AGFA notified all consignees via registered letter on/about 06/28/2007 informing them of the potential problem and requesting the accounts ensure the visual synchronization indicators in the Text and Image Areas are used to verify the synchronization status of the Text and Image Areas. A FAX Back form was requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A Mandatory Service Bulletin was deployed to correct the problem in the software.
Quantity in Commerce 154 units
Distribution U.S. Nationwide and Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA CORP.
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