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U.S. Department of Health and Human Services

Class 2 Device Recall RM, RMAT

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  Class 2 Device Recall RM, RMAT see related information
Date Initiated by Firm June 11, 2010
Date Posted July 29, 2010
Recall Status1 Terminated 3 on July 02, 2013
Recall Number Z-2112-2010
Recall Event ID 56090
510(K)Number K050228  
Product Classification Electrocardiograph - 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 SC 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.