BEUDAMED
    FDA Recall Terminated

    Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.

    Recall: Z-0802-2013 · Initiated November 1, 2010

    Recall

    Recall Number
    Z-0802-2013
    Event Number
    60695
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DRY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 1, 2010
    Posted
    February 12, 2013
    Terminated
    November 8, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.

    Reason

    Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.

    Action

    Terumo sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 1, 2010 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions or concerns.

    Distribution

    Worldwide Distribution.

    Quantity

    622 units