BEUDAMED
    FDA Recall Terminated

    PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".

    Recall: Z-2116-2010 · Initiated May 27, 2010

    Recall

    Recall Number
    Z-2116-2010
    Event Number
    55874
    Firm
    Sonosite, Inc.
    FEI Number
    3002087856
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 27, 2010
    Posted
    August 2, 2010
    Terminated
    April 18, 2011
    Address
    21919 30th Dr Se, Bothell, WA, 98021-3904

    Description

    PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".

    Reason

    PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.

    Action

    On 05/27/10, SonoSite began contacting their consignees by telephone. On 06/01/10, SonoSite sent out the URGENT-MEDICAL DEVICE RECALL letter to their consignees. The letter describes the recall product as SonoSite PowerPark. Customers should call the Technical Support at 1-877-657-8118 or e-mail to [email protected] for any questions regarding the recall. The letter instructs consignees to stop using the PowerPark immediately and return the product back to SonoSite in exchange for a full refund. The consignees will be contacted by the firm's Sales Representative and/or Clinical Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.

    Distribution

    Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.

    Quantity

    26