Site-Rite 9770086RRecalls & reported problems
Bard Access Systems, Inc. · REFURB, SR PREVUE PLUS ULTRASOUND SYSTEM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Site-Rite Prevue Plus ultrasound system is an imaging system with a probe. Many of the 113 reports describe poor image quality, a screen that is too dark or flickering, the software freezing, or unexpected shutdowns, and some describe a cracked housing. The reports include no injuries and no deaths, and 32 note no consequences to the patient. 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
- 113
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00801741124945), received between Feb 2, 2018 and Apr 6, 2026 — classified as 113 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (44 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 Image44
- Defective Component36
- No Apparent Adverse Event14
- Application Program Freezes or Fails to Launch13
- Unexpected Shutdown8
- No Display/Image5
- Battery Problem3
- Erratic or Intermittent Display3
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- No Consequences Or Impact To Patient32
- No Known Impact Or Consequence To Patient23
- No Information2
Recent adverse event reports
The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Poor Quality Image
IT WAS FOUND DURING EVALUATION AT BD SERVICE CENTER: THE IMAGE APPEARS YELLOWISH. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793635 ↗MalfunctionNov 4, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SCREEN IS TOO DARK, SETTINGS WILL NOT CHANGE HOW DARK IT IS WHEN USING THE PROBE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23471900 ↗MalfunctionSep 3, 2025Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
FOUND DURING EVALUATION AT BD SERVICE CENTER: THERE IS A DARK VERTICAL LINE IN THE ULTRASOUND IMAGE DUE TO THE DAMAGED PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22954569 ↗MalfunctionJun 19, 2025Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
IT WAS REPORTED THAT THE IMAGES ARE TOO DARK TO SEE ANYTHING EVEN THOUGH THE REST OF THE DISPLAY IS NORMAL BRIGHTNESS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292219 ↗MalfunctionDec 22, 2023Defective Component; Defective Component
IT WAS FOUND DURING AN INVESTIGATION THAT THE BACK ENCLOSURE HAS A CRACK THAT GOES FROM THE TRIPOD MOUNT TO THE BLACK FOAM AROUND THE MANUFACTURES SERIAL LABEL. THE BACK ENCLOSURE IS ALSO CRACKED AT THE TOP OF THE PROBE HOLDER. THE PROBE¿S HOUSING IS SEPARATING AND THE STRAIN RELIEF IS DAMAGED. THE ULTRASOUND IMAGE HAS INTERFERENCE / NOISE ON THE RIGHT SIDE. THE BATTERY WILL NOT CHARGE TO 100%.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18389271 ↗MalfunctionDec 1, 2023Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
IT WAS REPORTED THE SCREEN IS TOO DARK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18245528 ↗MalfunctionOct 26, 2023Erratic or Intermittent Display; No Apparent Adverse Event; Erratic or Intermittent Display; No Apparent Adverse Event
IT WAS REPORTED THE SCREEN IS FLICKERING ON AND OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18011638 ↗MalfunctionSep 13, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE LEFT QUARTER OF SCREEN IS DISTORTED/FUZZY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17736268 ↗MalfunctionJul 14, 2023Poor Quality Image; Poor Quality Image
MalfunctionMay 5, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY BIOMED - RECENT SCANNING DISPLAYS/PICTURES ARE SLIGHTLY DISTORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16875845 ↗MalfunctionJan 26, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY THE CUSTOMER "IMAGE IS NOT FULLY SHOWING ON THE SCREEN." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251265 ↗MalfunctionJan 26, 2023Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THE PROBE HOUSING IS BUSTED AND THEY SAY THE IMAGE IS A LITTLE GRAINY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251236 ↗MalfunctionDec 1, 2022Defective Component; Defective Component
THE SCREEN BECOMES GRITTY. (B)(6)/2022 - THE RETURNED DEVICE DISPLAYED INTERFERENCE AND A POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15893440 ↗MalfunctionNov 30, 2022Defective Component; Defective Component
THE UNIT NO OUTPUT FROM THE PROBE. THE SCREEN IS BLANK OTHER THAN THE ELECTRONIC OVERLAYS. ON 11/22/2022 FOUND DURING EVALUATION: THE UNIT BOOTS TO A DARK ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15889886 ↗MalfunctionNov 9, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
PER BIOMED - WHEN THEY ATTACH THE GEL IT WILL NOT REGISTER THE SCANNER. WHEN IT FINALLY CONNECTS, MONITOR IS NOT CLEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15764650 ↗MalfunctionNov 9, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
PER BIOMED - WHEN THEY ATTACH THE GEL IT WILL NOT REGISTER THE SCANNER. WHEN IT FINALLY CONNECTS, MONITOR IS NOT CLEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15764592 ↗MalfunctionNov 9, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
THERE ARE DARK VERTICAL LINES ON THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15764399 ↗MalfunctionOct 19, 2022Defective Component; Defective Component
BATTERY WILL NOT HOLD A CHARGE. 10/17/2022 EVALUATION FOUND SYSTEM TO SHUTDOWN ABRUPTLY WHEN UNPLUGGED FROM AC POWER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15636186 ↗MalfunctionOct 12, 2022No Apparent Adverse Event; Unexpected Shutdown; No Apparent Adverse Event; Unexpected Shutdown
DEVICE SHUTS OFF RANDOMLY EVEN WITH FULL BATTERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15590901 ↗MalfunctionOct 6, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
THE UNIT DISPLAYS A POOR IMAGE QUALITY WITH DARK LINES IN THE ULTRASOUND IMAGE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15548071 ↗MalfunctionSep 15, 2022Defective Component; Defective Component
IMAGE OF SCAN IS BLACKED OUT ON RIGHT SIDE. ON 09/13/2022 EVALUATION AT BD SERVICE FACILITY FOUND PART OF THE ULTRASOUND IMAGE IS DARK ON THE RIGHT SIDE OF THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15431710 ↗MalfunctionSep 14, 2022Defective Component; Unexpected Shutdown; Defective Component; Unexpected Shutdown
PER BIOMED, NOT CHARGING AND TURNING OFF RANDOMLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15418776 ↗MalfunctionSep 14, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
PER BIOMED - NO CLEAN IMAGE AND HAS WHITE LIGHT IN BACKGROUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15418616 ↗MalfunctionAug 31, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
THE IMAGE QUALITY IS BAD. THE CUSTOMER STATES IT'S TOO DARK AND THEY CAN'T ADJUST THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327323 ↗MalfunctionAug 30, 2022Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
THE DEVICE DISPLAYS A DARK ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15321397 ↗
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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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