Date Initiated by Firm |
March 23, 2009 |
Date Posted |
June 12, 2009 |
Recall Status1 |
Terminated 3 on January 20, 2010 |
Recall Number |
Z-1422-2009 |
Recall Event ID |
51681 |
510(K)Number |
K040207 K994011
|
Product Classification |
External Programmable Pacemaker Pulse Generator - Product Code JOQ
|
Product |
EP-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. |
Recalling Firm/ Manufacturer |
St. Jude Medical 575 Route 73 North, Bldg D Cooper Run Executive Park West Berlin NJ 08091
|
For Additional Information Contact |
Angela 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 |
Action |
All 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 Commerce |
694 total (US, Canada, and OUS) |
Distribution |
Worldwide distribution. |
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 = JOQ and Original Applicant = EP MEDSYSTEMS 510(K)s with Product Code = JOQ and Original Applicant = EP MEDSYSTEMS, INC.
|