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 Z-0802-2012 · Posted 2012-01-26
Advertisement
Recalling FirmNellcor Puritan Bennett Inc. (dba Covidien LP)
Recall StatusTerminated
Product CodeGXY
Date Initiated2011-11-08
Date Terminated2013-03-13
Product Quantity8510 units (851 boxes of 10)
Reason for Recall
During manufacture, circuit traces were reversed which causes inaccurate display of information.
Firm 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.
Root Cause
Finished device change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement