BIS 186-0199-RFBRecalls & reported problems
Covidien LP · BISX Module,Refurbished, Software Version 1.15 · Class 2
All models of BIS (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521129825), received between Jan 3, 2024 and Dec 30, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (4 reports).
1 other recall cover devices cleared under the same FDA submission (K072286); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement4
- Device Damaged Prior to Use1
- High Readings1
Patient problems
- Insufficient Information5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DEVICE HAD INCORRECT READINGS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 23928035 ↗MalfunctionJun 26, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT DID NOT PROVIDE RELIABLE DATA. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19617375 ↗MalfunctionFeb 2, 2024Incorrect Measurement; Device Damaged Prior to Use; Incorrect Measurement; Device Damaged Prior to Use
ACCORDING TO THE REPORTER, THE DEVICE HAD INCORRECT PATIENT DATA AND WAS BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME
Patient problems: Insufficient Information
MAUDE report 18636744 ↗MalfunctionFeb 2, 2024Incorrect Measurement; Incorrect Measurement
ACCORDING TO THE REPORTER, THE UNIT WOULD NOT GIVE CORRECT DATA. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18636124 ↗MalfunctionJan 3, 2024High Readings; High Readings
ACCORDING TO THE REPORTER, UNIT HAD HIGH READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 18435996 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072286. One submission often covers many models, so check the product and lot details in each record.
- Z-2958-2018 · Jul 26, 2018 · Open, ClassifiedLi-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
Other Index-generating electroencephalograph software devices
- BIS 186-1046Covidien LP · Index-generating electroencephalograph software102 reports
- BIS 186-0224-AMSCovidien LP · Index-generating electroencephalograph software1 death41 reports
- BIS 186-0195-AMSCovidien LP · Index-generating electroencephalograph software38 reports
- BIS Module IntelliVue BIS ModulePhilips Medizin Systeme Böblingen GmbH · Index-Generating Electroencephalograph Software15 reports
- BIS 186-0195-NKCovidien LP · Index-generating electroencephalograph software11 reports
- BIS 186-1001-RFBCovidien LP · Index-generating electroencephalograph software6 reports
- BIS PMB4000Covidien LP · Index-generating electroencephalograph software5 reports
- BIS 186-0299-RFBCovidien LP · Index-generating electroencephalograph software4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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