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/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 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 |
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
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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.
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