PHILIPS BIS Module 862293Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838021105), received between Jan 12, 2026 and Mar 25, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Incorrect Measurement
THE CUSTOMER REPORTED THAT THE UNIT WAS GIVING INACCURATE READING. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687220 ↗MalfunctionJan 12, 2026Unable to Obtain Readings
IT WAS REPORTED THAT THE SIGNAL QUALITY INDES (SQI) VALUE IS LOW, STAYS AT 0. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037179 ↗
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- Seer Home SM-01-8001Seer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Seer Home Monitoring PortalSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Sedline® Seditation Monitor 9513Masimo Corporation · Full-montage Standard Electroencephalograph38 reports
- NA DAQ916Medtronic Xomed, Inc. · Full-montage Standard Electroencephalograph27 reports
- SedLine™ EEG Sensor 2479Masimo Corporation · Full-montage Standard Electroencephalograph14 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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