Date Initiated by Firm |
October 22, 2010 |
Date Posted |
December 29, 2010 |
Recall Status1 |
Terminated 3 on February 01, 2011 |
Recall Number |
Z-0835-2011 |
Recall Event ID |
57110 |
510(K)Number |
K081976
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa Mammography Keypad allows users the ability to apply hot keys from a keypad versus a keyboard. |
Code Information |
504RU000 |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
|
For Additional Information Contact |
Debbie Norris 864-421-1754
|
Manufacturer Reason for Recall |
Product did not receive UL Certification
|
FDA Determined Cause 2 |
Other |
Action |
AGFA sent an Urgent Safety Notice letter dated October 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to unplug existing keypad(s) including USB cable. Plug in loaner Keypad(s). Print out the Fed Ex shipping label that they received via the e-mail notification. Use that label to ship their existing keypad(s) and their corresponding USB cables to the manufacturer. The manufacturer would perform the upgrades and return the keypad(s) along with the USB cables.
Upon receipt of the original keypad(s) customers would also receive another e-mail notification with a shipping label so that they may return the loaner keypad(s) to AGFA HealthCare.
Customers were to distribute this information to all those who need to be aware of it, and complete the feedback form as soon as possible and return it to AGFA HealthCare.
For questions regarding this recall call 838-342-3989.
. |
Quantity in Commerce |
26 units |
Distribution |
Worldlwide Distribution - USA including FL, GA, KY, ME, MD, MS, OH, UT and the country of Canada |
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.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = AGFA HEALTHCARE CORPORATION
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