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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All System, Monitoring, Perinatal devices →

Sources and updates

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