Recall Z-0802-2012 ยท GXY Electrode, Cutaneous
Nellcor Puritan Bennett Inc. (dba Covidien LP)
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
| Date | Jan 26, 2012 (initiated Nov 8, 2011) |
| Status | Terminated |
| Reason | During manufacture, circuit traces were reversed which causes inaccurate display of information. |
| Root cause | Finished device change control |
| 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. |
| Quantity | 8510 units (851 boxes of 10) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062692 | BIS BILATERAL SENSOR Aspect Medical Systems, Inc., Dec 13, 2006 |