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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAX Network Gateway Server, License Key

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 Class 2 Recall
IMPAX Network Gateway Server, License Key
see related information
Date Posted July 01, 2008
Recall Status1 Terminated on July 21, 2010
Recall Number Z-1306-2008
Recall Event ID 46812
Product Classification System, Digital Image Communications, Radiological - Product Code LMD
Product IMPAX® 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.
Code Information ABC Code EXEGE000
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
864-828-1827
Manufacturer Reason
for Recall
Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
Action On 12/11/07, AGFA Healthcare sent out an e-mail to all affected consignees informing them of the situation. The firm also arranged to install the corrected License Key on all affected units of the product.
Quantity in Commerce 12 units
Distribution Nationwide Distribution - USA, including states of CA, GA, IA and SD.
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.
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