BEUDAMED
    FDA Recall Terminated

    BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.

    Recall: Z-0802-2012 · Initiated November 8, 2011

    Recall

    Recall Number
    Z-0802-2012
    Event Number
    60372
    Firm
    Nellcor Puritan Bennett Inc. (dba Covidien LP)
    FEI Number
    2936999
    Product Code
    GXY
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    November 8, 2011
    Posted
    January 26, 2012
    Terminated
    March 13, 2013
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

    BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological (such as EEG) signals. The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patients forehead. BIS technology is used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.

    Reason

    During manufacture, circuit traces were reversed which causes inaccurate display of information.

    Action

    Covidien sent an Urgent Medical Device Recall letter dated November 8, 2011, to all affected customers. The letter identified the product, problem, and actions to be taken. Customers were instructed to segregate and return any product with the affected lot numbers according to the directions provided. If product was further distributed, the recall was to be continued to those customers. Further information is available at 800-635-5267.

    Distribution

    Nationwide Distribution (USA) including the states of: AZ, CA, CO, FL, GA, IL, KY, KS, LA, MA, MO, MS, NC, NM, NY, OH, PA, SD, TN, TX, UT, VA, WA, WI, WV and WY.

    Quantity

    8510 units (851 boxes of 10)