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U.S. Department of Health and Human Services

Class 2 Device Recall Agfa HeartLab Cardiovascular DICOMstore

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  Class 2 Device Recall Agfa HeartLab Cardiovascular DICOMstore see related information
Date Initiated by Firm June 21, 2007
Date Posted June 27, 2008
Recall Status1 Terminated 3 on August 04, 2008
Recall Number Z-1241-2008
Recall Event ID 46381
510(K)Number K050228  
Product Classification Echocardiogram (ECG) System - Product Code LLZ
Product Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
Code Information DICOMstore, L9M8E, Software version: 2.04.40.00
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Ray B. Myers Ph.D
864-828-1827
Manufacturer Reason
for Recall
MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
FDA Determined
Cause 2
Software design
Action On 6/21-26/2007, AGFA Healthcare notified, via telephone, the affected consignees of the situation. On 7/2/2007, affected consignees were sent, via registered mail, an "Urgent Medical Device Correction" letter instructing them to: a) remove the affected software DICOMstore 2.04.40.00 and replace it with the prior software version, DICOMstore 2.04.34.02; and b) review patient ECG reports to determine if any patients were actually affected and to notify the firm. AGFA Healthcare also provided a customer service contact number (877) 777-2432.
Quantity in Commerce 43 units
Distribution Worldwide Distributution - USA, including states of AZ, CA, DC, FL, IL, IN, KY, MA, ME, MN, MS, OH, OK, OR, NH, PA, SC, TN, TX, WI, and country of 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.
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