Site-Rite 9770086Recalls & reported problems
Bard Access Systems, Inc. · SITE-RITE PREVUE PLUS ULTRASOUND SYSTEM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a Bard Site-Rite PreVue Plus ultrasound system, a portable ultrasound machine used for imaging blood vessels. The 57 reports mostly describe poor or distorted images, frozen or crashed screens, and units that shut off or need frequent rebooting, with one report of discomfort. There are no deaths, one injury, and 56 malfunctions. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00801741095450), received between Dec 21, 2017 and Feb 19, 2026 — classified as 1 injury, 56 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (28 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.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image28
- Defective Component12
- No Apparent Adverse Event6
- Application Program Freezes or Fails to Launch5
- No Display/Image4
- Crack3
- Unexpected Shutdown3
- Failure to Align2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient8
- Discomfort4
- Burning Sensation1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Product Quality Problem
IT WAS REPORTED THE UNIT IS GIVING EC101. A REBOOT CLEARS THE ERROR BUT THEY ARE HAVING TO REBOOT IT EVERY TIME THEY USE THE MACHINE. 18 FEB 2026 EVALUATION FOUND SNOW AT THE BOTTOM OF THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392770 ↗MalfunctionDec 9, 2025Premature Discharge of Battery; No Display/Image; Premature Discharge of Battery; No Display/Image
IT WAS REPORTED THAT THE SCREEN IS PIXILATED OR FROZE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23763962 ↗MalfunctionJul 31, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE UNIT WILL REBOOT AUTOMATICALLY THEN ASK PROMPT TO HIT F1 TO CONTINUE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22682779 ↗MalfunctionNov 22, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED BY BIOMED - UNIT IS FREEZING UP INTERMITTENTLY. ALSO SEEMS TO BE GETTING WARM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20761082 ↗MalfunctionMay 22, 2024Defective Component; Defective Component
IT WAS REPORTED OBSERVATION FOUND DURING EVALUATION: THE PREVUE BOOTS TO A DARK ULTRASOUND IMAGE DUE TO AN INTERNAL FAILURE WITHIN THE BEAMFORMER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372211 ↗MalfunctionMay 22, 2024Defective Component; Defective Component
IT WAS REPORTED OBSERVATION FOUND DURING EVALUATION: THE SCANNER DISPLAYS HALF OF AN ULTRASOUND IMAGE DUE TO THE PROBE CONNECTOR NOT FULLY CONNECTED TO THE BEAMFORMER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372209 ↗MalfunctionNov 15, 2023Defective Component; Defective Component
THE FOLLOWING WAS FOUND DURING EVALUATION AT BD SERVICE CENTER: THE PREVUE FAILS TO CHARGE AND SHUTS OFF ABRUPTLY WHEN DISCONNECTED FROM AC POWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18139612 ↗MalfunctionAug 9, 2023Break; Defective Component; Break; Defective Component
IT WAS REPORTED THE PROBE STRAIN RELIEF WIRES ARE EXPOSED ON BOTH ENDS OFF THE PROBE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17495176 ↗MalfunctionJan 28, 2023Poor Quality Image; Poor Quality Image
IT WAS FOUND DURING EVALUATION THAT THE TOP HALF OF THE ULTRASOUND SCREEN IS BLACK WITH LINES THROUGH IT DUE TO AN INTERNAL FAILURE WITHIN THE LCD DISPLAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261251 ↗MalfunctionJan 10, 2023Poor Quality Image; Poor Quality Image
DURING EVALUATION OF THE RETURNED DEVICE, DARK VERTICAL LINES IN THE ULTRASOUND IMAGES WERE FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16131249 ↗MalfunctionJan 5, 2023Defective Component; Defective Component
UNIT ONLY LASTS 10 MINUTES ON BATTERY. (B)(6) 2022 FOUND DURING EVALUATION: SYSTEM SHUTS DOWN AT 50%.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16109510 ↗MalfunctionJan 3, 2023Poor Quality Image; Poor Quality Image
DURING EVALUATION OF THE RETURNED DEVICE, DARK VERTICAL LINES IN THE ULTRASOUND IMAGE WERE FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16087410 ↗MalfunctionDec 15, 2022Poor Quality Image; Poor Quality Image
FOUND DURING EVALUATION AT A SERVICE FACILITY: THE ULTRASOUND SCREEN DISPLAYS A POOR IMAGE QUALITY AND DARK VERTICAL LINES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15992724 ↗MalfunctionOct 12, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
THERE IS A DARK VERTICAL LINE IN THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15587906 ↗MalfunctionOct 12, 2022Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
THE PICTURE IS GRAINY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15587881 ↗MalfunctionAug 30, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
THE UNIT DISPLAYS A POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320505 ↗MalfunctionAug 11, 2022Imprecision; No Apparent Adverse Event; Imprecision; No Apparent Adverse Event
PER BIOMED - THE DEPTH SEEMS TO BE OFF BY ABOUT .5 CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15210457 ↗MalfunctionJul 7, 2022Poor Quality Image; Poor Quality Image
PER TM - THE STAFF IS SAYING THE IMAGE IS TO DARK, THEY ARE NOT ABLE TO SEE ANYTHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14946975 ↗MalfunctionJun 17, 2022Poor Quality Image; Poor Quality Image
BLACK LINES/IMAGE NOT CLEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734280 ↗MalfunctionApr 14, 2022Defective Component; Defective Component
OBSERVATION FOUND DURING EVALUATION: DURING THE ASSESSMENT IT WAS FOUND THAT UNIT DISPLAYED A DARK IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14112351 ↗MalfunctionApr 1, 2022Erratic or Intermittent Display; No Apparent Adverse Event; Erratic or Intermittent Display; No Apparent Adverse Event
PER BIOMED - THE CLINICIAN ARE STATING WHILE SCANNING THE IMAGE WILL JUMP TO ANOTHER SCREEN/VIEW SPONTANEOUSLY. THEY BELIEVE THE SCREEN JUMPING CORRESPONDS WITH A POPPING NOISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13977449 ↗MalfunctionDec 21, 2021No Apparent Adverse Event; Application Program Freezes or Fails to Launch; No Apparent Adverse Event; Application Program Freezes or Fails to Launch
PER TM: SCREENS FREEZES AND WILL STOP WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13053703 ↗MalfunctionNov 18, 2021Poor Quality Image; Poor Quality Image
PER BIOMED: THE IMAGE QUALITY IS POOR AND GETS WORSE THE DEEPER THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12836827 ↗MalfunctionNov 18, 2021Poor Quality Image; Poor Quality Image
PER BIOMED: THE IMAGE QUALITY IS POOR AND GETS WORSE THE DEEPER THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12836653 ↗MalfunctionNov 11, 2021Defective Component; Defective Component
OBSERVATION FOUND DURING EVALUATION: THERE IS A DARK VERTICAL LINE IN THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12800638 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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