Recall Z-0835-2011 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
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.
| Date | Dec 29, 2010 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | Product did not receive UL Certification |
| Root cause | 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 or |
| Quantity | 26 units |
| Distribution | Worldlwide Distribution - USA including FL, GA, KY, ME, MD, MS, OH, UT and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION Agfa Healthcare Corporation, Jul 28, 2008 |