Site~Rite 8 Ultrasound System 9770601Recalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System 32mm 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 8 ultrasound probe is a diagnostic transducer used with ultrasound systems. Its 102 FDA reports mostly describe poor image quality, with some reports of broken parts, buttons that stop working, and display glitches. The reports include no deaths and no injuries. 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
- 103
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00801741138294), received between Nov 13, 2018 and Sep 24, 2026 — classified as 103 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (87 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 Image87
- No Apparent Adverse Event29
- Defective Component9
- Break6
- Image Display Error/Artifact2
- No Display/Image2
- Product Quality Problem2
- Device Displays Incorrect Message1
Patient problems
- No Clinical Signs, Symptoms or Conditions81
- No Consequences Or Impact To Patient15
- No Known Impact Or Consequence To Patient9
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Poor Quality Image
It was reported that the probe does not detect point. No patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883613 ↗MalfunctionSep 21, 2026Poor Quality Image
It was reported that the image quality is poor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843281 ↗MalfunctionSep 21, 2026Poor Quality Image
It was reported that the image quality is poor.No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842473 ↗MalfunctionSep 15, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778969 ↗MalfunctionSep 10, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714932 ↗MalfunctionAug 25, 2026Break; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433149 ↗MalfunctionMay 5, 2026Poor Quality Image
IT WAS REPORTED THE PROBE HAS POOR IMAGE QUALITY. NO PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087496 ↗MalfunctionApr 27, 2026Poor Quality Image
IT WAS FOUND AT A SERVICE CENTER THERE IS A BLACK AREA IN THE CENTER OF THE IMAGE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009440 ↗MalfunctionApr 22, 2026Device Displays Incorrect Message
IT WAS REPORTED THAT WHEN USING THE PROBE, IT IS CAUSING A GLITCH AND LOSING CONNECTION. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954286 ↗MalfunctionMar 24, 2026Poor Quality Image
IT WAS REPORTED GRAINY IMAGE QUALITY. VERIFIED THEY ADJUSTED THE FILTERS. CUSTOMER SAID ISSUE HAS BEEN GETTING PROGRESSIVELY WORSE OVER TIME. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676899 ↗MalfunctionMar 18, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THE CUSTOMER SEES CHANGES IN THE IMAGE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627259 ↗MalfunctionFeb 19, 2026Poor Quality Image
IT WAS REPORTED THAT TRANSDUCER IS BLURRY WHEN PERFORMING ULTRASOUND. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388477 ↗MalfunctionFeb 12, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED, THE ULTRASOUND IMAGE APPEARS TO BE DARK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323852 ↗MalfunctionFeb 12, 2026Poor Quality Image
IT WAS REPORTED, IMAGES ARE FUZZY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323850 ↗MalfunctionJan 27, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED THE CUSTOMER IS HAVING IMAGE QUALITY ISSUES AND HAVE TRIED ADJUSTING THE CONTRAST AND BRIGHTNESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193810 ↗MalfunctionDec 30, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED PROBE IS IN POOR CONDITION, THE IMAGE LOOKS TOO DARK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927233 ↗MalfunctionDec 12, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED, POOR IMAGE QUALITY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789670 ↗MalfunctionNov 11, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGES ARE NOT CLEAR. NO OTHER INFORMATION PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526993 ↗MalfunctionSep 9, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY THE CUSTOMER "THE SCREEN VIEW IS VERY 'GRAINY' AND POOR QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007443 ↗MalfunctionSep 9, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THERE IS A LARGE ARTIFACT IN THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006677 ↗MalfunctionAug 27, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED PROBE HAS VERY POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903809 ↗MalfunctionAug 27, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE UNIT HAS POOR IMAGE QUALITY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903017 ↗MalfunctionJul 23, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGES HAVE STREAKS ON THEM, THAT ALMOST LOOKS LIKE LIGHTNING FLASHES. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22583624 ↗MalfunctionJul 16, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE ARE IMAGE PROBLEMS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523155 ↗MalfunctionJul 10, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMAGE QUALITY IS BAD. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22473378 ↗
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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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