BEUDAMED
    FDA Recall Terminated

    Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.

    Recall: Z-2443-2010 · Initiated June 30, 2010

    Recall

    Recall Number
    Z-2443-2010
    Event Number
    56121
    Firm
    Osypka Medical Inc
    FEI Number
    3004185614
    Product Code
    DTE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2010
    Posted
    September 21, 2010
    Terminated
    August 10, 2012
    Address
    7855 Ivanhoe Ave, Ste 226, La Jolla, CA, 92037-4561

    Description

    Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.

    Reason

    The recall was initiated after Osypka Medical received two (2) complaints from their Japanese distributor regarding an incompatibility of the PACE 203H with some new types of 9 V batteries. The investigation revealed that PACE 203H of a certain manufacturing period malfunction (i.e., not stimulate) when a type of 9 V batteries with higher than usual open circuit voltage (OCV) is used. Failure t

    Action

    OSYPKA Medical sent "Urgent Medical Device Recall" letters dated June 30, 2010 and July 7, 2010 to the direct customers. The recall notice informed the customers of the Reason for Recall, the Potential Hazard, the Temporary Fix of the Problem, the Permanent Fix of the Problem and Recommended Actions to be taken by the customer. The customers were instructed to contact Osypka Medical via telephone (858) 454-0021 or e-mail to [email protected] to verify that the Model 3085 and/or PACE 203H is subject to this product removal, obtain a return-to-manufacturer-authorization (RMA) number ,and then return the affected devices to Osypka Medical. If you have any questions call (858) 454-0021 or e-mail to [email protected]

    Distribution

    Nationwide Distribution: USA including states of CA & FL

    Quantity

    205 units (US Only)