IMPAX CV Results Manager/Results Manager Administration Tool
FDA device recall Z-2112-2010 · posted 2010-07-29 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
- Action taken
- A letter was sent to the consignee on 6/11/2010 indicating what steps would be taken by Agfa concerning the problem. The letter also included a feedback form which was to be returned to Agfa. The recall was expanded and a "URGENT SAFETY NOTICE" was sent to each additional consignee on January 25, 2012. The letter described the potential issue and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the additional consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 358
- Distribution
- AK, AZ, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI and Canada
- Date initiated
- 2010-06-11
- Date posted
- 2010-07-29
- Date terminated
- 2013-07-02
- 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 |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |