BEUDAMED
    FDA Recall Terminated

    Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.

    Recall: Z-2014-2008 · Initiated May 29, 2008

    Recall

    Recall Number
    Z-2014-2008
    Event Number
    48163
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 29, 2008
    Posted
    September 16, 2008
    Terminated
    August 18, 2011
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.

    Reason

    HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use.

    Action

    On 6/4/08, the firm sent letters to their customers via UPS. The letter informed the customers of the recall, and informed them of the following: "Customers who previously purchased and received a model C7-3 Biopsy Guide Starter Kit between November 29, 2005 and April 3, 2008 will receive a new kit at no charge, to replace the incomplete C7-3 kit previously purchased. New C7-3 kits will be distributed to affected customers by June 30, 2008. Please discard immediately the old C7-3 Biopsy Guide Kit... Customers who previously purchased and received model C5-2 and/or model L9-5 will find the respective new user manual enclosed with this letter. Please discard any old user manuals for models C5-2 and L9-5. The old C5-2 and L9-5 user manual is identified by part number 1-041-7385-02 and 1-041-7587-02 respectively. The part number is located in the lower left hand margin of the single page document." Included with the letter is a form to be faxed back to Philips indicating they have received the notice and forwarded it onto any sub accounts. If you have questions, contact your local field service representative or Beth Brouillette at 978-659-4884.

    Distribution

    Products are distributed to 5 medical facilities located in NY, WA, GA, VA and MI and to 51 foreign consignees located in AR, AT, CH, CN, CO, CY, DE, DK, ES, FR, GB, GR, HK, HR, HU, IN, IT, KR, LB, LV, MA, MD, MY, NI, NL, PL, SG, SV, TH, TR, TW, ZA.

    Quantity

    35 units