Date Initiated by Firm |
February 16, 2006 |
Date Posted |
April 22, 2006 |
Recall Status1 |
Terminated 3 on June 23, 2006 |
Recall Number |
Z-0788-06 |
Recall Event ID |
34773 |
Product Classification |
Mammography film - Product Code IWZ
|
Product |
Mamoray¿ HDR-C PLUS Mammography film |
Code Information |
Product Code: EMLOV, Batch 37300052 |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
|
For Additional Information Contact |
Customer Support Center 877-777-2432
|
Manufacturer Reason for Recall |
The film was incorrectly notched.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on/about 02/16/2006. |
Quantity in Commerce |
16523 units |
Distribution |
Nationwide |
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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