Avalon Ultrasound Transducer USA Avalon US Transducer USARecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Avalon US Transducer USA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838021488), received between Jan 25, 2021 and Sep 17, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn, Thermal1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2024Signal Artifact/Noise; Signal Artifact/Noise
IT WAS REPORTED THAT THE AVALON US TRANSDUCER GIVES A NOISY SIGNAL AND HAS TROUBLE GIVING MEASUREMENT. IT IS UNCLEAR IF THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. A REQUEST FOR CONFIRMATION OF DEVICE USE HAS BEEN SENT, A RESPONSE IS PENDING. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238280 ↗MalfunctionJul 18, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
THE CUSTOMER REPORTED THAT THE TRANSDUCER SHOCKED THE PATIENT. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17343009 ↗InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT A PATIENT WAS BURNED BY A AVALON US TRANSDUCER. YES, DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ISSUE. FURTHER DETAILS ABOUT THE PATIENT, SUCH AS AGE, HEIGHT AND WEIGHT HAD NOT BEEN MADE AVAILABLE AT THE TIME OF THE REPORTING DECISION.
Patient problems: Burn, Thermal
MAUDE report 11222309 ↗
Other TRANSDUCER, ULTRASONIC, OBSTETRIC devices
- Fetal monitor F2Edan Instruments, Inc. · Transducer, Ultrasonic, Obstetric1 recall0 reports
- Fetal Monitor F3Edan Instruments, Inc. · Transducer, Ultrasonic, Obstetric1 recall0 reports
- Avalon US TransducerPhilips Medizin Systeme Böblingen GmbH · TRANSDUCER, ULTRASONIC, OBSTETRIC2 deaths29 reports
- Avalon CL Ultrasound Transducer Avalon Cableless US TransducerPhilips Medizin Systeme Böblingen GmbH · TRANSDUCER, ULTRASONIC, OBSTETRIC1 death3 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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