Recall Z-2112-2010 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool
| Date | Jul 29, 2010 (initiated Jun 11, 2010) |
| Status | Terminated |
| Reason | Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |