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U.S. Department of Health and Human Services

Class 3 Device Recall Mammography Keypad

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 Class 3 Recall
Mammography Keypad
see related information
Date Posted December 29, 2010
Recall Status1 Terminated on February 01, 2011
Recall Number Z-0835-2011
Recall Event ID 57110
Premarket Notification
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, South Carolina 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/UNDETERMINED: Pending
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

 
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.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = AGFA HEALTHCARE CORPORATION
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