BEUDAMED
    FDA Recall Terminated

    SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021".

    Recall: Z-2655-2010 · Initiated November 2, 2007

    Recall

    Recall Number
    Z-2655-2010
    Event Number
    49387
    Firm
    Sonosite, Inc.
    FEI Number
    3002087856
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 2, 2007
    Posted
    October 1, 2010
    Terminated
    October 5, 2010
    Address
    21919 30th Dr Se, Bothell, WA, 98021-3904

    Description

    SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021".

    Reason

    Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer.

    Action

    On November 2, 2007, SonoSite sent out the Important Information Regarding Sterrad NX Incompatibility letter and the Technical Bulletin 005/07 Rev A to their consignees. The letter advises the consignees that SonoSite has recently found that sterilization of the SonoSite SLT and LAP surgical ultrasound transducers with the Sterrad NX system may result in damage to the transducer. The Technical Bulletin 005/07 Rev B dated November 2, 2007 informs the consignees that the damage has been observed primarily on the circuit board in the transducer connector, and cable and laparoscope damage may also be occurring. All damages have occurred after processing using the Sterrad NX systems in its "Advanced" cycle and the potential damage from the use of "normal" cycle is being evaluated by the firm. Consignees should call the Technical Support at 1-425-951-1330 or 1-877-657-8118 or e-mail to [email protected] for any questions regarding the recall.

    Distribution

    Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.

    Quantity

    38 units