Avalon ECG/IUP 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 18, 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 00884838093201), received between Oct 18, 2021 and Oct 18, 2021 — classified as 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.
Most reported problems
Device problems
- Incorrect Measurement2
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.
MalfunctionOct 18, 2021Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THE ECG/IUP TRANSDUCER DOES NOT WORK, AFTER REPLACING THE CABLE, THE TRACING IS NOT CORRECT. PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647045 ↗MalfunctionOct 18, 2021Incorrect Measurement; Incorrect Measurement
IN THIS CASE, IT WAS REPORTED THE "ECG/IUP TRANSDUCER DOES NOT WORK, AFTER REPLACING THE CABLE, THE TRACING IS NOT CORRECT. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12646601 ↗
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
- Central Monitoring System MFM-CNS LiteEdan Instruments, Inc. · System, Monitoring, Perinatal1 recall0 reports
- Fetal & maternal monitor F6 ExpressEdan 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
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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