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U.S. Department of Health and Human Services

Class 2 Device Recall RM, RMAT

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 Class 2 Recall
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Date Posted July 29, 2010
Recall Status1 Open
Recall Number Z-2112-2010
Recall Event ID 56090
Premarket Notification
510(K) Number
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX CV Results Manager/Results Manager Administration Tool
Code Information Model No. L9M2100; Software Versions RM All versions of the CV Reporting (RM) are now affected.
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Jeffery A. Jedlicka
Manufacturer Reason
for Recall
Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
FDA Determined
Cause 2
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 in Commerce 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
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.