SpO2 Sensor Reusable Adult SpO2 SensorRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Reusable Adult SpO2 Sensor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838010215), received between Feb 13, 2026 and May 8, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (2 reports).
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 Measurement2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Erythema1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON REUSABLE ADULT SPO2 SENSOR INDICATING THAT THE SPO2 MEASUREMENT IN INCORRECT AT BASELINE. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123594 ↗MalfunctionMay 4, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON REUSABLE ADULT SPO2 SENSOR INDICATING THAT THE SPO2 MEASUREMENT IN INCORRECT AT BASELINE. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073222 ↗InjuryFeb 13, 2026Insufficient Device Problem Information
PHILIPS RECEIVED A COMPLAINT ON A REUSABLE ADULT SPO2 SENSOR INDICATING THAT THE PATIENT DEVELOPED REDNESS UNDER THE SPO2 SENSOR. THE PATIENT COMPLAINED OF PAIN ON THE LEFT HAND WHERE THE SPO2 SENSOR WAS PLACED. ON THE SECOND AND THIRD FINGERS, REDNESS AND INCREASED WARMTH WERE NOTED ON THE NAIL BEDS AND KNUCKLES. THE SPO2 SENSOR WAS THEN MOVED TO SECOND FINGER ON THE RIGHT HAND BUT AFTER APPROXIMATELY 10 MINUTES, REDNESS APPEARED AT THE SAME LOCATION. AFTER THIS TIME, MONITORING WAS CONCLUDED AS THE PATIENT WAS SENT UP TO THE WARD. IT WAS UNCLEAR WHETHER THIS WAS A THERMAL INJURY OR AN ALLERGIC REACTION.
Patient problems: Erythema; Pain
MAUDE report 24331623 ↗
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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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