BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1422-2009 · Initiated March 23, 2009

    Recall

    Recall Number
    Z-1422-2009
    Event Number
    51681
    Firm
    St. Jude Medical
    FEI Number
    2126673
    Product Code
    JOQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 23, 2009
    Posted
    June 12, 2009
    Terminated
    January 20, 2010
    Address
    575 Route 73 North, Bldg D, Cooper Run Executive Park West Berlin, NJ, 08091

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Worldwide distribution.

    Quantity

    694 total (US, Canada, and OUS)