| Class 2 Device Recall Agfa HeartLab Cardiovascular DICOMstore | |
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
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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
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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 |
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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
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