Avalon Toco+ Transducer (REF 867249)Recalls & 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 00884838093225), received between Aug 12, 2025 and Sep 14, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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, Inadequate or Imprecise Result or Readings2
- 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.
MalfunctionSep 14, 2026No Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763291 ↗MalfunctionAug 10, 2026Unable to Obtain Readings
Philips received a complaint on an Avalon TOCO Transducer indicating that at the first measurement the sensor freezes on the value and does not move. The device was in use on a patient at time of event, there was no adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193154 ↗MalfunctionFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE TOCO+ TRANSDUCER WITH SERIAL NUMBER (B)(6), WHICH BELONGS TO THE FETAL MONITOR WITH SERIAL NUMBER (B)(6), IS BROKEN. IT WAS INDICATED THAT IT DOES NOT MEASURE CORRECTLY, NOR DOES IT CALIBRATE THE BASELINE CORRECTLY. 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 24285327 ↗MalfunctionAug 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PHILIPS RECEIVED A COMPLAINT ON AN AVALON TOCO+ TRANSDUCER INDICATING THAT THE BREAKDOWN THAT THE TOCO PRESENTS NEVER GOES ABOVE 120 BPM, YOU TRY WITH ANOTHER TOCO AND THERE IS A DIFFERENCE IN THE MEASUREMENTS. IT IS UNKNOWN IF THIS ISSUE WAS WITH THE FETAL HEART RATE OR MATERNAL HEART RATE. IT WAS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787217 ↗
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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