BEUDAMED
    FDA Recall Terminated

    UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.

    Recall: Z-1749-2008 · Initiated January 18, 2008

    Recall

    Recall Number
    Z-1749-2008
    Event Number
    47536
    Firm
    Otsuka America Pharmaceutical, Inc.
    FEI Number
    3000718406
    Product Code
    JJQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 18, 2008
    Posted
    September 1, 2008
    Terminated
    February 18, 2011
    Address
    2440 Research Blvd, Rockville, MD, 20850-3238

    Description

    UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.

    Reason

    Medical device power supply may overheat and cause smoke to be emitted from the device.

    Action

    The initial distributor in the US notified consignees 03/14/08 and 03/26/08 by letter. Consignees were provided two different letters depending on the hours of use of the spectrophotometer. The notifications advised of the firm's preventive service and upgrade program for the instrument's power supply, in which consignees would receive a temporary replacement instrument while the service is completed. Consignees with spectrophotometers having <15000 light source hours were notified similarly, and were provided filters and instructions for cleaning and replacing the filters to protect the power supply from unnecessary accumulation of debris. Contact firm at 1-888-MERETEK for assistance.

    Distribution

    The affected medical devices were distributed to medical facilities and physician offices nationwide and to distributors in Mexico.

    Quantity

    517 units