FDA Recall Terminated

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.

Recall: Z-0835-2011 · Initiated October 22, 2010

Recall

Recall Number
Z-0835-2011
Event Number
57110
Firm
AGFA Corp.
FEI Number
3001236302
Product Code
LLZ
Status
Terminated
Root Cause
Other
Initiated
October 22, 2010
Posted
December 29, 2010
Terminated
February 1, 2011
Address
10 S Academy St, Greenville, SC, 29601-2632

Description

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.

Reason

Product did not receive UL Certification

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. .

Distribution

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

Quantity

26 units