BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US)

    Recall: Z-2481-2010 · Initiated September 10, 2010

    Recall

    Recall Number
    Z-2481-2010
    Event Number
    55911
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 10, 2010
    Posted
    September 23, 2010
    Terminated
    December 20, 2011
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US)

    Reason

    The design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly depletes over time. At the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas syst

    Action

    Terumo issued a URGENT MEDICAL DEVICE CORRECTION letter dated September 10, 2010, identifying the affected product, the issue prompting the correction, and what actions are to be taken by the customer. The firm included the addendum to the operators manual with the recall letter. The addendum recommended replacement of the oxygen sensor every six months instead of every 12 months. The addendum provided additional user instructions in the event of a calibration failure of the sensor. Customers are to complete and return the enclosed Customer Response Form to the firm. Terumo CVS Customer Service can be contacted by 1-800-521-2818 Monday through Friday, 8 AM 6 PM EST.

    Distribution

    Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, and WV, and the countries of Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Phiippines and Thailand.

    Quantity

    1315