FDA Medical Device Recalls (openFDA)
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 used as an adjunct to clinical judgement and training. Reliance on BIS technology alone for intraoperative anesthetic management is not recommended.
- Recall number
- Z-0802-2012
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-11-08
- Posted
- 2012-01-26
- Terminated
- 2013-03-13
- 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.
- Lot, serial or model codes
- Lot numbers: 0528111A, 0603111A, 0604111A, 0606111A, 0607111A, 0608111A, 0609111A, 0615111A, 0620111A, 0621111A, 0624111A, 0625111A, 0627111A, 0701111A, 0707111A, 0712111A, 0713111A, 0725111A, 0726111A, 0726111B, 0727111A, 0727111B, 0728111A, 0728111B, 0729111A, 0729111B, 0801111A, 0808111A, 0809111A, 0810111A, 0811111A, 0812111A, 0813111A, 0814111A, 0820111A, 0821111A, 0822111A, 0822111B, 0823111A, 0823111B, 0824111A, 0824111B, 0825111A, 0825111B, 0826111A, 0826111B, 0921111A, 0923111A, 0923111B, 0924111A, 0926111A, 0927111A, 0930111A, 1001111A, 1003111A, 1004111A, 1005111A, 1006111A.
- 510(k) numbers
- K062692
- PMA numbers
- not on file
- Product code
- GXY
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28