Avalon Toco+ MP TransducerRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · The device is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838093188), received between Sep 24, 2024 and Jun 18, 2026 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement2
- Incorrect, Inadequate or Imprecise Result or Readings1
- No Audible Prompt/Feedback1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON AN AVALON TOCO+ MP TRANSDUCER INDICATING THAT THE TOCO PROBE IS NOT FUNCTIONING. NOTES INDICATE AN IMPACT OF WRONG VALUES PRODUCED. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25546415 ↗MalfunctionNov 18, 2025Unable to Obtain Readings; No Audible Prompt/Feedback; Unable to Obtain Readings; No Audible Prompt/Feedback
PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WAS NO HEART SOUND RECORDING. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582266 ↗MalfunctionNov 14, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DATA FROM TRANSDUCER IS INACCURATE/NULL, THE WAVEFORM INTERMITTENTLY GOES FLAT. 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 23556006 ↗MalfunctionSep 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE AVALON TOCO+ MP TRANSDUCER DOES NOT MEASURE ACCURATELY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20294443 ↗
Other System, Monitoring, Perinatal devices
- Avalon Fetal Monitor FM30 Avalon FM30 Fetal MonitorPhilips Medizin Systeme Böblingen GmbH · SYSTEM, MONITORING, PERINATAL1 recall11 deaths142 reports
- Avalon Fetal Monitor FM20 Avalon FM20 Fetal MonitorPhilips Medizin Systeme Böblingen GmbH · SYSTEM, MONITORING, PERINATAL1 recall126 reports
- Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbH · System, Monitoring, Perinatal1 recall2 deaths41 reports
- Avalon Fetal Monitor FM50 Avalon FM50 Fetal MonitorPhilips Medizin Systeme Böblingen GmbH · SYSTEM, MONITORING, PERINATAL9 deaths51 reports
- Fetal & maternal monitor F6Edan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
- Fetal & maternal monitor F9Edan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
- Central Monitoring System MFM-CNSEdan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
- Central Monitoring System MFM-CNS LiteEdan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 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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