Site-Rite 9770500Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00801741096891), received between Dec 14, 2017 and Aug 27, 2025 — classified as 140 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (46 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED CUSTOMER IS HAVING IMAGE ISSUES ON ATTACHED PROBE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903798 ↗
• MalfunctionAug 21, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROBE IS PRODUCING UNCLEAR IMAGES. THE CLINICIANS HAVE ADJUSTED SETTINGS TO TRY AND FIX THE ISSUE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861729 ↗
• MalfunctionAug 6, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE CUSTOMER PROBE IS HAVING IMAGE QUALITY ISSUES AS THE IMAGES ARE BLURRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728738 ↗
• MalfunctionJul 16, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE SR8 UNIT POWERS OFF WHEN UNIT IS UNPLUGGED FROM POWER. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523976 ↗
• MalfunctionJun 10, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED PROBE IS GIVING BLURRY IMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179152 ↗
• MalfunctionJan 6, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THAT THE UNIT HAS A BLURRY SCREEN, BAD IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085207 ↗
• MalfunctionNov 7, 2024Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED, POOR IMAGE QUALITY. TRIED SEVERAL DIFFERENT SETTINGS, PROBLEM PERSISTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632992 ↗
• MalfunctionSep 11, 2024Defective Component; Unexpected Shutdown; Defective Component; Unexpected Shutdown

  IT WAS FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE SR8 SHUTS OFF ABRUPTLY WHEN AC POWER IS DISCONNECTED, AND THE SCANNER WILL NOT POWER ON WITHOUT AC POWER. THESE ISSUES ARE DUE TO AN INTERNAL FAILURE WITHIN THE LITHIUM-ION BATTERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192679 ↗
• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED WIRES SHOWING FROM PROBE CORD AND/OR HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270796 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED THAT THE CORD HAS PULLED AWAY ON BOTH THE CONNECTOR END AND THE PROBE END. PLASTIC HAS BROKEN AND IS EXPOSING WIRING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040488 ↗
• MalfunctionDec 5, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED BY THE CUSTOMER THE PROBE FACE ON ATTACHED PROBE IS DEGRADING CAUSING A POOR IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266925 ↗
• MalfunctionSep 21, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THE IMAGES ARE VERY FUZZY, AND HAVE LINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795332 ↗
• MalfunctionSep 14, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THE PROBE IS GIVING BLURRY IMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17752957 ↗
• MalfunctionSep 13, 2023Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THE CORD IS PULLING AWAY/EXPOSING WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736196 ↗
• MalfunctionSep 13, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED BY BIOMED - SCREEN RESOLUTION IS NO LONGER CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736052 ↗
• MalfunctionJul 18, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED BY A TM - THE ULTRASOUND IMAGE IS HARD TO SEE AND THAT IT WAS NEVER LIKE THAT IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343307 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED STRAIN RELIEF WIRES ARE EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318646 ↗
• MalfunctionJul 5, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED IMAGES ARE NO LONGER CRISP AND CHANGING CONTRAST OR FILTERS IS NOT HELPING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259601 ↗
• MalfunctionJun 23, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THE UNIT WILL NOT WORK UNLESS PLUGGED IN, AND SOMETIMES STILL SHUTS DOWN IN THE MIDDLE OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191595 ↗
• MalfunctionJun 5, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED BY A TM - THE IMAGE IS BLURRY, AND THE TIP CAN'T BE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059552 ↗
• MalfunctionMay 18, 2023Break; Break

  FOUND DURING EVALUATION OF ORIGINAL FILE: THE DC CONNECTOR ON THE POWER SUPPLY THAT WAS PROVIDED WITH THIS UNIT IS BROKEN, THE STRAIN RELIEF IS CRACKED AND THE WIRES ARE BROKEN INTERNALLY EXPOSING THE WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959398 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THE PROBE COVER IS MISSING AND WIRES ARE EXPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753025 ↗
• MalfunctionMar 10, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THE SCREEN HAS ALL OF THE SUDDEN BECOME DARK AND CLOUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522865 ↗
• MalfunctionMar 10, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  IT WAS REPORTED THE CUSTOMER'S SR8 IS HAVING ISSUES WITH IMAGES BEING GRAINY AND/OR NOISY. HE FEELS THE CRYSTALS ON THE PROBE HAVE BEEN DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522680 ↗
• MalfunctionFeb 10, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event

  THE CUSTOMER REPORTED HAVING IMAGE ISSUES WITH THEIR PROBE. VERIFIED CURRENT SOFTWARE VERSION IS INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16348482 ↗