Site~Rite 8 Ultrasound System 9770602Recalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe · Class 2
All models of Site~Rite 8 Ultrasound System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Site Rite ultrasound probe has 123 adverse event reports, with no deaths or injuries. Most reports describe poor or dark images, with black lines or streaks across the picture, and some describe the system freezing or showing no image when the probe is connected. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 122
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 00801741138324), received between Mar 2, 2018 and Jun 9, 2026 — classified as 122 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (84 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image84
- Defective Component15
- No Display/Image10
- Break8
- Image Display Error/Artifact7
- Application Program Freezes or Fails to Launch4
- No Apparent Adverse Event3
- Display or Visual Feedback Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Consequences Or Impact To Patient41
- No Known Impact Or Consequence To Patient26
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 122 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE PROBE IS CAUSING THE SR8 TO FREEZE UP WHEN IT IS PLUGGED IN. BIOMED TRIED THE PROBE ON SEVERAL DIFFERENT SR8'S AND ALL OF THEM FROZE WHEN THIS PROBE WAS PLUGGED IN. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446084 ↗MalfunctionFeb 11, 2026Poor Quality Image
IT WAS FOUND DURING EVALUATION AT BD SERVICE CENTER: THE PROBE HAS BLACK LINE IN THE MIDDLE OF THE IMAGE OF THE IMAGE. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316526 ↗MalfunctionOct 15, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGING IS NOT CLEAR, "LOOKS LIKE ITS RAINING". NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303181 ↗MalfunctionSep 17, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE HAD DEGRADED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23073156 ↗MalfunctionSep 10, 2025Poor Quality Image; Poor Quality Image
OBSERVATION FOUND DURING EVALUATION AT BD SERVICE CENTER: THERE ARE BLACK LINES ON THE LEFT SIDE OF THE IMAGE. THERE IS A BLACK SECTION ON THE RIGHT SIDE OF THE IMAGE THAT RUNS TOP TO BOTTOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23016083 ↗MalfunctionSep 9, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED POOR IMAGE QUALITY/DARK IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23008077 ↗MalfunctionSep 9, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED POOR IMAGE QUALITY/DARK IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007340 ↗MalfunctionJun 4, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGES ARE DARK AND BLURRY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143456 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT THE CORD HAS PULLED AWAY AT THE STRAIN RELIEF EXPOSING WIRES. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762478 ↗MalfunctionOct 24, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, PROBE IS GIVING VERY DARK IMAGES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524470 ↗MalfunctionOct 9, 2024Poor Quality Image; Poor Quality Image
IT WAS FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE PROBE HAS RAIN ALL OVER THE IMAGE DUE TO AN INTERNAL FAILURE OF THE PROBE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20411136 ↗MalfunctionSep 6, 2024Break; Break
IT WAS REPORTED, PROBE WIRE INSULATION IS PARTIALLY CUT EXPOSING WIRING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163164 ↗MalfunctionJun 5, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE PROBE HAS ARTIFACTS ON THE IMAGES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19471949 ↗MalfunctionMay 8, 2024Break; Break
IT WAS REPORTED THE PROBE HAS CRACKED HOUSING AND IS EXPOSING WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19270797 ↗MalfunctionMar 4, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT WHEN PROBE IS PLUGGED INTO SR8, IT CAUSES THE SCREEN TO FREEZE UP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18827444 ↗MalfunctionFeb 29, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
PER CUSTOMER - CAUSES SCREEN TO FREEZE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18812869 ↗MalfunctionFeb 9, 2024Poor Quality Image; Poor Quality Image
CUSTOMER REPORTS ARTIFACTS AND VISUAL SNOW IN IMAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18681312 ↗MalfunctionJan 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE PROBE IS HAVING IMAGE/NOISE ISSUES UP TOWARDS THE TOP OF THE IMAGE. VERIFIED THEY HAVE ADJUSTED FILTERS AND CONTRAST SETTINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18485288 ↗MalfunctionJan 3, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY BIOMED - THE SHOWING RAIN OR SNOW ON THE SCREEN WHEN IT¿S BEING USED ON A PATIENT WHICH IS AN ARTIFACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18440728 ↗MalfunctionDec 7, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY A TM - CUSTOMER IS COMPLAINING THAT THE IMAGE QUALITY IS VERY POOR WITH THIS PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18288504 ↗MalfunctionNov 2, 2023Defective Component; Defective Component
IT WAS FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE PROBE HAS A DARK SPOT IN THE MIDDLE OF THE IMAGE DUE TO AN INTERNAL FAILURE OF THE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18055195 ↗MalfunctionOct 4, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THE UNIT DISPLAYING LOTS OF RAIN AT THE BOTTOM OF THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17873242 ↗MalfunctionSep 14, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE PROBE IMAGE IS FUZZY WITH LOTS OF STATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17752966 ↗MalfunctionJul 26, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THERE'S A SHADOW TO THE LEFT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17400506 ↗MalfunctionJun 23, 2023Break; Break
IT WAS REPORTED THE CABLE IS DAMAGED AT THE END OF THE STRAIN RELIEF. (B)(6) 2023 IT WAS FOUND DURING AN INVESTIGATION THE PROBE CABLE IS SEPARATING FROM THE STRAIN RELIEF WHICH IS EXPOSING WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17190234 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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