RecallDepth

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.

Company
Agfa Corp.
Recall Initiated
October 22, 2010
Posted
December 29, 2010
Terminated
February 1, 2011
Recall Number
Z-0835-2011
Quantity
26 units
Firm Location
Greenville, SC

Reason for Recall

Product did not receive UL Certification

Distribution

Worldlwide Distribution - USA including FL, GA, KY, ME, MD, MS, OH, UT and the country of Canada

Lot / Code Info

504RU000

Root Cause

Other

Action Taken

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. .

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