Avalon CL ECG/IUP Transducer Avalon Cableless ECG/IUP TransducerRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Avalon Cableless ECG/IUP Transducer for use with Avalon CL Basestation 866074. ECG/IUP Transducer with connector for maternal ECG, fetal ECG or IUP measurement. · 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 00884838034259), received between Feb 3, 2022 and Feb 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (1 report).
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 Measurement1
- No Audible Alarm1
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.
MalfunctionFeb 15, 2026No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON AN AVALON CABLELESS ECG/IUP TRANSDUCER INDICATING THAT THERE WAS NO SOUND. 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 24341611 ↗MalfunctionFeb 3, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE AVALON CABLELESS ECG/IUP TRANSDUCER PRODUCE INACCURATE IUP READINGS. NO PATIENT INVOLVED IN THIS CASE. THE ISSUE WAS DISCOVERED WHILE A TECHNICIAN WAS PERFORMING REGULAR MAINTENANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13443723 ↗
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- MR Patient Care Short Wide ECG 2.0 Cable AAMI CAB,4 LD,CV MRI ECGPhilips Ds North America LLC · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)12 reports
- NA 5492ALMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5492VLMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5487LMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)8 reports
- NA 5487Medtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)6 reports
- CORE M2 Vascular System 400-0100.17Volcano Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)6 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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