IMPAX CV Results Manager/Results Manager Administration Tool
- Company
- Agfa Corp.
- Recall Initiated
- June 11, 2010
- Posted
- July 29, 2010
- Terminated
- July 2, 2013
- Recall Number
- Z-2112-2010
- Quantity
- 358
- Firm Location
- Greenville, SC
Reason for Recall
Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
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
Lot / Code Info
Model No. L9M2100; Software Versions RM 2.08.12.00.00. All versions of the CV Reporting (RM) are now affected.
Root Cause
Other
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.