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U.S. Department of Health and Human Services

Class 3 Device Recall EP4 Stimulator

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 Class 3 Device Recall EP4 Stimulatorsee related information
Date Initiated by FirmMarch 23, 2009
Date PostedJune 12, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall NumberZ-1422-2009
Recall Event ID 51681
510(K)NumberK040207 K994011 
Product Classification External Programmable Pacemaker Pulse Generator - Product Code JOQ
ProductEP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 North, Units D, West Berlin, NJ 08091. Indicated for use during clinical electrophysiology procedures.
Code Information Systems Part Numbers: EP-4I-2-110; EP-4I-2-220; EP-4I-4-110; EP-4-220: WM-01M-241; WM-01M-560; WM-01M-1200; WM-02M-241; WM-02M-560; and WM-02M-1200.
FEI Number 2126673
Recalling Firm/
Manufacturer		 St. Jude Medical
575 Route 73 North, Bldg D
Cooper Run Executive Park
West Berlin NJ 08091
For Additional Information ContactAngela Craig
856-753-8533
Manufacturer Reason
for Recall		Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.
FDA Determined
Cause 2		Device Design
ActionAll foreign customers were sent Urgent Product Safety Information letters on March 23, 2009. Letters described units affected, the reason for action, and the actions to take to eliminate risk. It is recommended that the information in the letter be circulated to all users, risk managers and the biomedical engineering department responsible for maintaining and inspecting electrical equipment located within their institution. The letter also stated that a SJM representative will be in touch to perform the EP-4 Stimulator fuse modification. Customers are to complete and return the attachment.
Quantity in Commerce694 total (US, Canada, and OUS)
DistributionWorldwide distribution.
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 = JOQ
510(K)s with Product Code = JOQ
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