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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 Device Recall IMPAX Network Gateway Server, License Key see related information
Date Initiated by Firm December 11, 2007
Date Posted July 01, 2008
Recall Status1 Terminated 3 on July 21, 2010
Recall Number Z-1306-2008
Recall Event ID 46812
Product Classification Medical image communications device - 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/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D.
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
Release of Material/Component prior to receiving 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 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.