Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and dia
FDA device recall Z-0835-2011 · posted 2010-12-29 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Product did not receive UL Certification
- 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. .
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 26 units
- Distribution
- Worldlwide Distribution - USA including FL, GA, KY, ME, MD, MS, OH, UT and the country of Canada
- Date initiated
- 2010-10-22
- Date posted
- 2010-12-29
- Date terminated
- 2011-02-01
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION (K081976) | Agfa Healthcare Corporation | 2008-07-28 |