BEUDAMED
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    ORTHOSIS, SPINAL PEDICLE FIXATION

    FDA Adverse Event
    Malfunction ·RELIANCE MEDICAL SYSTEMS, LLC·Product code MNI·January 3, 2020

    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.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code GXY·November 8, 2011