Z-0835-2011

Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their...

Name: Z-0835-2011 Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their...
Creator: AGFA Corp.
Published: 2010-10-22
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2010-10-22 / Terminated

FDA source

AGFA Corp. began a recall of Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa... on 2010-10-22. The reason FDA records is "Product did not receive UL Certification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0835-2011
Status: Terminated
Initiated: 2010-10-22
Posted: 2010-12-29
Terminated: 2011-02-01
Recalling firm: AGFA Healthcare Corp.
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Product did not receive UL Certification
FDA 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 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
Product codes and lots: 504RU000

Product code LLZ

K081976Class IIImpax Ma3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation / cleared 2008-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)