Avalon CL Ultrasound Transducer Avalon Cableless US TransducerRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Avalon Cableless Ultrasound Transducer for use with Avalon CL Basestation 866074. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838034242), received between Dec 24, 2019 and Sep 14, 2026 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “High Readings” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- High Readings1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Death1
- Loss Of Pulse1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Incorrect Measurement
It was reported the device is not reading correctly. The device was not in clinical use. There was no report of patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755680 ↗MalfunctionAug 7, 2025High Readings; High Readings
IT WAS REPORTED THAT THE AVALON CABLELESS ULTRASOUND (US) TRANSDUCER WAS PRODUCING HIGH READINGS. 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 22737880 ↗DeathDec 24, 2019Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT "DURING THE BIRTH ON (B)(6) 2019, THERE WAS NO TRACE OF THE BABY'S HEART RATE FOR ABOUT 20 MINUTES. THE HEART RATE OF THE MOTHER WAS MEASURED. THE BABY WAS RESUSCITATED AFTER BIRTH, BUT DIED ON (B)(6) 2019.
Patient problems: Death; Loss Of Pulse
MAUDE report 9516077 ↗
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 Ultrasound Transducer USA Avalon US Transducer USAPhilips Medizin Systeme Böblingen GmbH · TRANSDUCER, ULTRASONIC, OBSTETRIC3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.