CHATTANOOGA 27335Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912021876), received between Jun 13, 2019 and Jul 13, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GETTING VERY HOT AND BURNED COUPLE OF OUR PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 19736585 ↗
• MalfunctionApr 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINT RECEIVED REPORTS THAT PATIENTS ARE RECEIVING UNINTENDED SHOCK WHEN USING ULTRASOUND. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE AT THIS TIME.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9981347 ↗
• MalfunctionApr 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  COMPLAINT RECEIVED REPORTS THAT PATIENTS ARE RECEIVING UNINTENDED SHOCK WHEN USING ULTRASOUND. DEVICE NOT RECEIVED MANUFACTURER AT THIS TIME. MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE AT THIS TIME.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9981345 ↗
• MalfunctionSep 25, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THERE WERE "HOT SPOTS AND INCONSISTENT THERMAL BENEFIT". NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9120057 ↗
• MalfunctionJul 5, 2019Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED THAT "THE ULTRASOUND HEAD MAKES CRACKLING SOUNDS WHEN USING ON PATIENTS AND SMOKE COMES FROM THE END OF THE ULTRASOUND HEAD. THE SMOKE IS WHITE AND NOTICEABLE." THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764847 ↗
• MalfunctionJun 13, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT "PATIENT REPORTED SENSATION OF BEING STABBED BY NEEDLES, AFTER FOUR MINUTES INTO THE LOW LEVEL ULTRASOUND PROCEDURE." USER FACILITY MEDWATCH # (B)(4) WAS FORWARDED TO THE MANUFACTURER, REPORTING THAT "PT WAS BEING ULTRASOUND WITH UNIT AND REPORTED A SENSATION OF BEING STABBED WITH A NEEDLE." THERE WAS NO ADVERSE EVENT INDICATED IN ASSOCIATION WITH THE REPORTED PRODUCT PROBLEM.

  Patient problems: Pain

  MAUDE report 8695850 ↗