Avalon Ultrasound TransducerRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00884838093195), received between May 8, 2024 and Oct 30, 2025 — classified as 2 deaths, 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “High Readings” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 22, 2024Class IIOpen, Classified

   Potential for inaccurate fetal heart rate measurements when monitoring multiples.

   Z-2239-2024 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON US TRANSDUCER INDICATING THAT THE VALUE IS NOT IN TOLERANCE. 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 23423292 ↗
• MalfunctionSep 12, 2025Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THE SENSOR DOES NOT GIVE THE CORRECT VALUES. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040248 ↗
• MalfunctionFeb 26, 2025Low Readings; Low Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THE HEART RATE MONITORED FROM THE TRANSDUCER IS LOW. 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 21468984 ↗
• MalfunctionFeb 18, 2025High Readings; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WERE INACCURATE FETAL HEART RATE (FHR) MEASUREMENTS WHEN MONITORING MULTIPLE FETUSES. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399623 ↗
• MalfunctionFeb 18, 2025High Readings; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WERE INACCURATE FETAL HEART RATE (FHR) MEASUREMENTS WHEN MONITORING MULTIPLE FETUSES. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399142 ↗
• MalfunctionFeb 18, 2025High Readings; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WERE INACCURATE FETAL HEART RATE (FHR) MEASUREMENTS WHEN MONITORING MULTIPLE FETUSES. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397392 ↗
• MalfunctionFeb 18, 2025High Readings; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WERE INACCURATE FETAL HEART RATE (FHR) MEASUREMENTS WHEN MONITORING MULTIPLE FETUSES. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395613 ↗
• MalfunctionDec 27, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN A PAIR OF TWINS IS BEING MONITORED ONE OF THE TRANSDUCERS WILL PICK UP A ABNORMAL RHYTHM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025774 ↗
• MalfunctionDec 27, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN A PAIR OF TWINS IS BEING MONITORED ONE OF THE TRANSDUCERS WILL PICK UP A ABNORMAL RHYTHM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025771 ↗
• MalfunctionDec 27, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN A PAIR OF TWINS IS BEING MONITORED ONE OF THE TRANSDUCERS WILL PICK UP A ABNORMAL RHYTHM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025766 ↗
• MalfunctionDec 27, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN A PAIR OF TWINS IS BEING MONITORED ONE OF THE TRANSDUCERS WILL PICK UP A ABNORMAL RHYTHM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025580 ↗
• MalfunctionDec 27, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN A PAIR OF TWINS IS BEING MONITORED ONE OF THE TRANSDUCERS WILL PICK UP A ABNORMAL RHYTHM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025459 ↗
• MalfunctionDec 27, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN A PAIR OF TWINS IS BEING MONITORED ONE OF THE TRANSDUCERS WILL PICK UP A ABNORMAL RHYTHM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025110 ↗
• MalfunctionDec 3, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHILE A PAIR OF TWINS WAS BEING MONITORED, ONE OF THE TRANSDUCERS PICKED UP A ABNORMAL RHYTHM. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833380 ↗
• MalfunctionOct 3, 2024Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THE DEVICE ACQUIRES AN INCORRECT MEASUREMENT. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359966 ↗
• MalfunctionSep 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WAS A VALUE PROBLEM. IT IS 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 20235560 ↗
• MalfunctionAug 21, 2024High Readings; High Readings

  THE CUSTOMER REPORTED THAT THE MONITOR HOOKED UP TO THE TWINS, SHOWED THE HEART RATE KEEPS GOING TO 200. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013685 ↗
• MalfunctionAug 13, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN MONITORING TWINS, THE FETAL HEART RATE (FHR) MEASURED BY THE US TRANSDUCER IS INACCURATE. THE HEART RATE IS HIGHER THAN THE VALUE MEASURED BY A STETHOSCOPE OR AN ECHOGRAPHY. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED. THE INVESTIGATION HAS BEEN ESCALATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977000 ↗
• MalfunctionAug 13, 2024High Readings; High Readings

  IT WAS REPORTED THAT WHEN MONITORING TWINS, THE FETAL HEART RATE (FHR) MEASURED BY THE US TRANSDUCER IS INACCURATE. THE HEART RATE IS HIGHER THAN THE VALUE MEASURED BY A STETHOSCOPE OR AN ECHOGRAPHY. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED. THE INVESTIGATION HAS BEEN ESCALATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974705 ↗
• MalfunctionAug 6, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE CUSTOMER REPORTED THAT THE MONITOR HOOKED UP TO THE TWINS, SHOWED THE HEART RATE KEEPS GOING TO 200. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920697 ↗
• MalfunctionAug 5, 2024Incorrect Measurement; High Readings; Incorrect Measurement; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCE INDICATING THAT THE SYSTEM CONTINUES TO SHOW TOO HIGH VALUES FOR FETAL HEART RATES 180BPM". THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT AND NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906612 ↗
• MalfunctionJul 19, 2024No Audible Alarm; No Audible Alarm

  BIOMED STATES THE US TRANSDUCER DOES NOT HAVE SOUND; NEEDS TO ORDER A REPLACEMENT TRANSDUCER. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19780247 ↗
• MalfunctionJul 11, 2024High Readings; High Readings

  IT WAS REPORTED THAT THE TWIN PREGNANCY IS RECORDING THE INCORRECT FHR (180BPM). THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.THE CUSTOMER HAS BEEN NOTIFIED THAT THIS IS A KNOWN ISSUE AND FCO86202016A IS EXPECTED TO BE IMPLEMENTED IN THE NEAR FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724302 ↗
• MalfunctionJul 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT "SYSTEM CONTINUES TO SHOW TOO HIGH VALUES FOR FETAL HEART RATES 180BPM". THE DEVICE WAS IN CLINICAL USE AT THE TIME OF EVENT AND NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647051 ↗
• DeathJul 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE SITE HAD TWO SENTINEL EVENTS DESCRIBED AS DEATH WITH UNKNOWN ROOT CAUSE. THE CUSTOMER WAS STILL COMPILING THEIR REPORT SO THEY DID NOT HAVE MUCH ADDITIONAL INFORMATION BUT THEY WERE WONDERING IF THE TRANSDUCER FIELD ACTION IMPACTED SINGLE WIRED TRANSDUCERS OR CABLELESS TRANSDUCERS. BASED ON THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THERE WAS ANY HARM RELATED TO PHILIPS DEVICES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19643577 ↗