Site~Rite 8 Ultrasound System 9770602YRecalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System 20mm Pinpoint GT Linear Probe (Remanufactured) · 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 8 ultrasound probe has 79 reports, no deaths or injuries, and no recalls. The reports mostly describe poor ultrasound images, artifacts, and parts such as strain relief or exposed wiring breaking.
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
- 78
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00801741138201), received between Sep 28, 2018 and Jan 23, 2026 — classified as 78 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image46
- Defective Component13
- Image Display Error/Artifact8
- No Apparent Adverse Event6
- No Display/Image6
- Break4
- Imprecision2
- Application Program Freezes or Fails to Launch1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient30
- No Known Impact Or Consequence To Patient14
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED, DAMAGED STRAIN RELIEF CAUSING ARTIFACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162776 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT THE CORD IS PULLING AWAY AT THE STRAIN RELIEF/EXPOSED WIRING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584270 ↗MalfunctionApr 5, 2024Poor Quality Image; Poor Quality Image
OBSERVATION FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE PROBE HAS A VERY RAINY IMAGE DUE TO AN INTERNAL FAILURE OF THE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19056174 ↗MalfunctionAug 28, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THE IMAGES ARE VERY BLURRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17638461 ↗MalfunctionJun 23, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE IMAGE QUALITY ON THE PROBE HAS DETERIORATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17190132 ↗MalfunctionApr 7, 2023Imprecision; Imprecision
IT WAS REPORTED THE PROBE IS GIVING INACCURATE, INTERMITTENT READINGS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16701353 ↗MalfunctionNov 9, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
THE IMAGE IS VERY POOR, IT DISPLAYS THREE BLACK VERTICAL LINES RUNNING DOWN THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15764727 ↗MalfunctionJul 29, 2022Poor Quality Image; Poor Quality Image
PER BIOMED - PROBE IS GIVING SNOW LIKE ARTIFACTS ON THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15129322 ↗MalfunctionJul 14, 2022Poor Quality Image; Poor Quality Image
THE PROBE IS GIVING A VERY RAINY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15013815 ↗MalfunctionJun 22, 2022Poor Quality Image; Poor Quality Image
CUSTOMER REPORTED IMAGE QUALITY FROM PROBE IS GETTING WORSE OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14774192 ↗MalfunctionMay 19, 2022Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
PER BIOMED - POOR IMAGE QUALITY/IMAGE DROPS OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14436285 ↗MalfunctionApr 21, 2022Poor Quality Image; Poor Quality Image
PER TM - THE IMAGE ON THE ULTRASOUND IS GETTING HARDER AND HARDER TO VISUALIZE THE VEINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14167751 ↗MalfunctionApr 14, 2022Defective Component; Defective Component
FOUND DURING EVALUATION: THE PROBE¿S IMAGE IS RAINY AND UNCLEAR. THERE IS A BLACK SPOT ON THE TOP LEFT SIDE OF THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112134 ↗MalfunctionApr 14, 2022Defective Component; Defective Component
PROBE IS SHOWING RAINING IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112129 ↗MalfunctionFeb 25, 2022Defective Component; Defective Component
FOUND DURING EVALUATION: THE PROBE DISPLAYS TWO BLACK VERTICAL LINES RUNNING VERTICALLY IN THE VIEWING AREA OF THE SCANNER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13599710 ↗MalfunctionFeb 11, 2022Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
CUSTOMER IS REPORTING RAIN IN THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13515142 ↗MalfunctionJan 27, 2022Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
PER BIOMED: THE IMAGE QUALITY IS SO POOR THAT THEY ARE HAVING ISSUES STARTING IV'S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13373227 ↗MalfunctionDec 21, 2021Poor Quality Image; Poor Quality Image
PER BIOMED, THE "CRYSTALS DROPPED OUT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13053412 ↗MalfunctionDec 8, 2021Break; Break
PER BIOMED: THE PROBE HAS INSULATION PEELING BACK AT THE NECK OF THE PROBE HEAD AND EXPOSING THE WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12965040 ↗MalfunctionOct 22, 2021Poor Quality Image; Poor Quality Image
PER TM - CUSTOMER IS REPORTING A RAINING INTERFERENCE IN THE LOWER THIRD OF THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681363 ↗MalfunctionOct 14, 2021Defective Component; Defective Component
FOUND DURING EVALUATION: THE PROBE IS GIVING BLACK LINE ON THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12631760 ↗MalfunctionOct 14, 2021Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
PER BIOMED - THE IMAGE QUALITY IS SO POOR THAT THEY ARE HAVING ISSUES STARTING IV'S WITH IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12631479 ↗MalfunctionSep 8, 2021Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
DURING EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE PROBE HAS RED MARKS ON THE CALIBRATION POINT AND PRODUCES RAIN LIKE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443219 ↗MalfunctionAug 26, 2021Poor Quality Image; Poor Quality Image
FOUND DURING EVALUATION: THE PROBE¿S IS GIVING A POOR IMAGE DUE TO AN INTERNAL FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12371297 ↗MalfunctionAug 18, 2021Defective Component; Defective Component
THE PROBE'S IMAGE SHOWS TWO BLACK LINES RUNNING DOWN VERTICALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12340364 ↗
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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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