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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, RMATsee related information
Date Initiated by FirmJune 11, 2010
Date PostedJuly 29, 2010
Recall Status1 Terminated 3 on July 02, 2013
Recall NumberZ-2112-2010
Recall Event ID 56090
510(K)NumberK050228 
Product Classification Electrocardiograph - Product Code LLZ
ProductIMPAX CV Results Manager/Results Manager Administration Tool
Code Information Model No. L9M2100; Software Versions RM 2.08.12.00.00. All versions of the CV Reporting (RM) are now affected.
FEI Number 3001236302
Recalling Firm/
Manufacturer		 AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information ContactJeffery A. Jedlicka
864-421-1815
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		Other
ActionA 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 Commerce358
DistributionAK, 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 CycleTPLC 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) Database510(K)s with Product Code = LLZ
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