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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 17, 2005
Date Posted July 19, 2005
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-1017-05
Recall Event ID 32465
PMA Number P910023/S77 P030054/S7 
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
Product Implantable Cardioverter Defibrilators

Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350)

Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).
Code Information No serial numbers were given. All models mentioned are affected.
Recalling Firm/
Manufacturer		 St Jude Medical
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Nestor Kusnierz
818-362-6822
Manufacturer Reason
for Recall		 Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.
FDA Determined
Cause 2		 Other
Action Recall was by letter to Physicians sent by FEDEX. Follow-up upgrade to programmers will be done by firm representatives to the new version 4.8.5.
Quantity in Commerce 30,000 domestically, 11,684 internationally
Distribution Nationwide and Sweden, Canada, Australia, New Zealand. South America and Asia
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.
PMA Database PMAs with Product Code = NIK and Original Applicant = Abbott Medical
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