BEUDAMED
    FDA Recall Terminated

    Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007

    Recall: Z-0671-2008 · Initiated November 8, 2007

    Recall

    Recall Number
    Z-0671-2008
    Event Number
    45800
    Firm
    Parks Medical Electronics Inc
    FEI Number
    3020115
    Product Code
    DPW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 8, 2007
    Posted
    July 3, 2008
    Terminated
    October 13, 2011
    Address
    19460 Sw Shaw St, Aloha, OR, 97007-1242

    Description

    Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007

    Reason

    Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter.

    Action

    811-B: On 9/28/07 Parks Medical Electronics notified their related U.S. distributor, Parks Medical Electronics Sales, Inc., Las Vegas, NV by email instructing them to stop further shipments. On 10/1/07 firm followed up with phone call instructing all units be returned for rework. On 11/8/07 firm sent replacement units accompanied with a Warranty Exchange Letter to their other U.S. customers notifying them of affected units. Letters were customized for each customer with a fill-in-the-blank of the model and serial numbers. Letters and replacement units were sent UPS 2nd Day Air and informed customer about the assembly error and instructions for returning the defective units. On 11/8/07 emails were sent to Brazilian and Australian distributors informing about assembly error and affected units. Rework instructions and a schematic were provided by email for each distributor to perform their own rework. On 11/28/97 Canadian customers were sent Warranty Exchange Letters and replacement units via UPS Ground. Firm is retrieving units from US and Canadian firms and will rework them. Firm is waiting to hear whether Brazilian or Austraian distributors need to sub-recall. Canadian distributors instructed to conduct subrecall if needed. All returned units will be reworked by disassembly of unit, removal of affected printed circuit board, washing board to remove acid flux, and testing.

    Distribution

    Worldwide Distribution - USA, Brazil, Australia, and Canada

    Quantity

    1 unit distributed to: Canadian veterinarian hospital on 9/26/07