Avalon US TransducerRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00884838002722), received between Nov 2, 2018 and Sep 30, 2026 — classified as 2 deaths, 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952444 ↗
• MalfunctionMar 10, 2026No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THE TRANSDUCER IS NOT WORKING AS NORMAL. INTERMITTENTLY WILL NOT PRODUCE SOUND. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557613 ↗
• MalfunctionDec 17, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON US TRANSDUCER INDICATING THAT THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED) STATED THE UNIT IS NOT MAKING ANY SOUND. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827283 ↗
• MalfunctionNov 24, 2025Low Readings; Low Readings

  IT WAS REPORTED THE ULTRASOUND TRANSDUCER SHOWS LOW MEASUREMENT. WHEN USED THE TRANSDUCER DISPLAYS A HEART RATE (HR) OF 60, HOWEVER WHEN THE CUSTOMER IS USING OTHER SENSORS, THESE GIVE A HR OF 130. 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 23631521 ↗
• MalfunctionNov 13, 2025Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE TRANSDUCER IS NOT TAKING CORRECT READINGS. THE DEVICE WAS IN CLINICAL 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 23547455 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TRANSDUCER LEFT SKIN WOUNDS WHERE THE MOST PRESSURE WAS APPLIED. THE SKIN WOUNDS APPEARED RED AND BLISTERED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. BASED ON DETAILS AVAILABLE AT THE TIME OF THIS REVIEW, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE REPORTED HARM MEETS CRITERIA FOR SERIOUS INJURY. THEREFORE, ADDITIONAL INFORMATION IS REQUESTED FOR FURTHER CLARIFICATION AND ASSESSMENT OF THE CUSTOMER¿S ALLEGED HARM(S).

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23346855 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE TRANSDUCER BECAME HOT AND LEFT SMALL CIRCULAR RED MARKS ON THE PATIENT, SIMILAR TO A BURN. THIS ISSUE DID NOT IMPACT PATIENT CARE OR CLINICAL WORKFLOW. THE TRANSDUCER WAS VISUALLY INSPECTED AND TESTED, REVEALING NO VISIBLE DAMAGE AND NO SIGNIFICANT TEMPERATURE INCREASE, WITH AND WITHOUT ULTRASOUND GEL. THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 23327591 ↗
• MalfunctionSep 15, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE AVALON US TRANSDUCER WAS NOT PRODUCED SOUND WHEN THE TRANSDUCER WAS PLUGGED IN TO A FETAL MONITOR. THE DEVICE WAS NOT 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 23050977 ↗
• InjuryAug 25, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THE PATIENT DEVELOPED A BURN ON THE SKIN UNDER THE DEVICE, WHICH WAS ASSUMED TO BE AN OVERHEATING ISSUE. THE HEATING ISSUE COULD NOT BE REPLICATED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Burn(s)

  MAUDE report 22883735 ↗
• MalfunctionJul 21, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER THAT NO HEART SOUNDS WAS AUDIBLE. IT UNKNOWN IF THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553576 ↗
• MalfunctionFeb 3, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THE AVALON US TRANSDUCER FETAL HEART RATE MEASUREMENT IS INACCURATE. IT IS UNCLEAR IF 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 21297148 ↗
• MalfunctionNov 13, 2024High Readings; High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THE READING WAS TOO HIGH. 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 20675830 ↗
• MalfunctionNov 5, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THERE WAS NOTHING AUDIBLE WHEN THE ARRESTER WAS ATTEMPTED, NO NOISE JUST COMPLETE SILENCE. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614044 ↗
• MalfunctionOct 9, 2024Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THERE WAS A DIFFERENCE IN VALUE. 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 20413958 ↗
• MalfunctionSep 26, 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 THE VALUES WERE NOT IN TOLERANCE. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313846 ↗
• 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 THE VALUES WERE NOT IN TOLERANCE. 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 20241330 ↗
• MalfunctionAug 27, 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 "VALUES NOT IN TOLERANCE, TONE" IT IS KNOWN THAT THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080787 ↗
• MalfunctionAug 26, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT NO SOUND WAS GENERATED WHEN TRYING TO DETERMINE FETAL HEART RATE DESPITE THE VOLUME BEING SET TO MAXIMUM. 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 20063790 ↗
• MalfunctionAug 7, 2024Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON US TRANSDUCER INDICATING THAT THE SENSORS MEASURE INCORRECT VALUES. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930405 ↗
• InjuryJul 24, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED AFTER USING THE ULTRASOUND TRANSDUCER, THE SKIN ON THE MOTHER'S ABDOMEN FORMED BLISTERS DUE TO BURNS. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19815783 ↗
• MalfunctionJul 1, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE FETAL HEART DATA WAS MISSING DURING MONITORING. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647789 ↗
• MalfunctionJun 13, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT THE FETAL HEART WAVEFORM WAS ABNORMAL. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533377 ↗
• DeathMar 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE AVALON FM30 FETAL MONITOR IS UNRELIABLE IN CAPTURING FETAL HEART RATE AND DISTINGUISHING IT FROM MATERNAL HEART RATE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, AN ADVERSE EVENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18933740 ↗
• MalfunctionDec 1, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE FETAL HEART MONITOR SHOWED 135 TIMES/MIN, BUT THE SOUND WAS OBVIOUSLY RAPID, AND THEN CARRIED OUT B-ULTRASOUND EXAMINATION, SHOWING THE FETAL HEART RATE OF 263 TIMES/MIN, AND TESTED WITH THE FETAL HEART MONITOR, SHOWING THAT THE FETAL HEART RATE WAS STILL ABOUT 135 TIMES/MIN. THIS WAS RESULTING IN A DOCTOR'S DIAGNOSIS ERROR, EMERGENCY TO THE OPERATING ROOM. PATIENT / USER HARM WAS REPORTED WITHOUT FURTHER DETAILS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS REPORT OF PATIENT OR USER HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245284 ↗
• MalfunctionOct 21, 2022Incorrect Measurement; Insufficient Device Problem Information; Incorrect Measurement; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THE CTG (CARDIOTOCOGRAPH) MACHINE SPONTANEOUSLY TURNED ITSELF BACK ON AND THEN RECORDED A TRACE WHICH WAS TACHYCARDIC AT 180BPM FOR OVER 90MINS. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENT AS THE MONITOR WAS NOT HOOKED UP TO THE PATIENT, NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15648102 ↗