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Class 2 Device Recall RM, RMAT |
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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
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Product Classification |
Electrocardiograph - Product Code LLZ
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Product |
IMPAX 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. |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
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For Additional Information Contact |
Jeffery A. Jedlicka 864-421-1815
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Manufacturer Reason for Recall |
Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
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FDA Determined Cause 2 |
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 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
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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