Site-Rite 9770090RRecalls & reported problems
Bard Access Systems, Inc. · REFURB, SITE-RITE PREVUE ULTRASOUND SYSTEM · Class 2
All models of Site-Rite (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Bard Site-Rite PreVue ultrasound system, a refurbished portable ultrasound machine used to get imaging inside the body. The 29 reports mostly describe image and power problems: poor or blank ultrasound pictures, screens going dark or freezing, black lines on the display, and batteries that won't hold a charge so the unit shuts off unexpectedly. No deaths or injuries were reported, and 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741124938), received between Jan 31, 2018 and Apr 7, 2023 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (8 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 16, 2026.
Most reported problems
Device problems
- Poor Quality Image8
- Battery Problem5
- Loss of Power5
- No Display/Image5
- Application Program Freezes or Fails to Launch2
- Charging Problem1
- Defective Component1
- Defective Device1
Patient problems
- No Consequences Or Impact To Patient14
- No Known Impact Or Consequence To Patient13
- No Information2
- Infiltration into Tissue1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2023Poor Quality Image; Poor Quality Image
TRADE IN NO ALLEGED DEFICIENCY. IT WAS FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE PREVUE DISPLAYS A DARK VERTICAL LINE IN THE ULTRASOUND IMAGE INTERMITTENTLY WHEN THE PROBE CABLE IS MOVED AROUND. THIS IS DUE TO AN INTERNAL FAILURE WITHIN THE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16698883 ↗MalfunctionOct 23, 2020No Display/Image
PER TM - SCREEN WILL NOT STAY ON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10731338 ↗MalfunctionOct 20, 2020Application Program Freezes or Fails to Launch
SCREEN FROZEN CAN ONLY SHUT DWON HOLDING POWER BUTTON SCREEN IN OP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10703598 ↗MalfunctionAug 7, 2020Loss of Power; Battery Problem; Loss of Power; Battery Problem
PER BIOMED, UNIT IS SHUTTING DOWN ABRUPTLY. EVEN WHEN INDICATING THAT IT'S FULLY CHARGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10378377 ↗MalfunctionJul 9, 2020No Display/Image; No Display/Image
PER BIOMED, UNIT DISPLAYS BLACK LINES DOWN THE TOUCHSCREEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10253585 ↗MalfunctionJul 1, 2020Battery Problem; Battery Problem
PER BIOMED, THE BATTERY WILL NOT HOLD A CHARGE. ON 06/11/2020 - DURING EVALUATION, IT WAS FOUND THE PREVUE SHUTS DOWN ABRUPTLY WITH REMAINING BATTERY POWER INDICATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10218688 ↗MalfunctionApr 23, 2020Loose or Intermittent Connection; Poor Quality Image; Loose or Intermittent Connection; Poor Quality Image
PER BIOMED, POOR PICTURE QUALITY AND UNIT NOT DOES NOT INDICATE WHEN TO PUT COVER ON PROBE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9990217 ↗MalfunctionMar 20, 2020Loss of Power; Battery Problem; Loss of Power; Battery Problem
PER BIOMED - THE SCANNER DOESN'T HOLD A CHARGE, WHEN IT IS UNPLUGGED IT SHUTS OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9859904 ↗MalfunctionJan 17, 2020No Display/Image; No Display/Image
PER BIOMED - THE SCANNER HAS A PARTIAL SCREEN, THE TOP HALF OF THE SCANNER IS DARK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9601177 ↗MalfunctionNov 7, 2019Loss of Power; Battery Problem; Loss of Power; Battery Problem
PER BIOMED - UNIT SHUTS OFF AS SOON AS AC POWER IS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9291319 ↗MalfunctionOct 3, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
PER BIOMED- THE SCANNER FREEZES UP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9152773 ↗MalfunctionSep 19, 2019Loss of Power; Battery Problem; Loss of Power; Battery Problem
PER BIOMED, BATTERY WON'T HOLD A CHARGE AND ABRUPTLY SHUTS DOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9090177 ↗MalfunctionSep 5, 2019Defective Component; Defective Component
STRAIN RELIEF AROUND PROBE HEAD HAS BEEN PULLED OUT, WITH EXPOSED WIRES.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8966954 ↗MalfunctionAug 29, 2019Premature Discharge of Battery; Loss of Power; Charging Problem; Loss of Power
PER BIOMED, UNIT WILL NOT HOLD A CHARGE. THE DEVICE WAS CHARGED ALL WEEKEND AND WITH 100% BATTERY IT SHUTS DOWN WHEN UNPLUGGED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8946959 ↗MalfunctionAug 9, 2019Poor Quality Image
PER BIOMED- THE PROBE HAS A POOR IMAGE QUALITY, THE IMAGE IS DARK.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8877597 ↗MalfunctionMay 23, 2019Failure to Power Up; Unexpected Shutdown
PER BIOMED, THE SCANNER SHUTS OFF WHEN IS NOT PLUGGED IN, ACCORDING TO THE BIOMED DEPARTMENT THE UNIT WAS UNRESPONSIVE WHEN HE TRIED TO TURN IT ON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8637695 ↗MalfunctionMay 9, 2019Display or Visual Feedback Problem
ONLY HALF THE SCREEN DISPLAYS CORRECTLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8597151 ↗MalfunctionApr 4, 2019Poor Quality Image
PER BIOMED: THE UNIT HAS POOR IMAGE QUALITY. "GRAINY, BLURRY, RAINY IMAGE".
Patient problems: No Information
MAUDE report 8484621 ↗MalfunctionMar 22, 2019Failure to Charge
PER VAT: THE PREVUE WILL NOT CHARGE. AC ADAPTER HAS BEEN CHANGED BUT MADE NO DIFFERENCE. THIS MACHINE IS USED ALMOST DAILY IN OUR FACILITY TO ASSIST WITH NEW AND DIFFICULT CANNULATIONS. SINCE IT STOPPED CHARGING ON (B)(6) 2019 THERE HAS BEEN AN INCREASE IN MULTIPLE CANNULATIONS AND INFILTRATIONS OF NEW FISTULAS. SOME PATIENTS ARE EVEN HAVING CANNULATIONS HELD DUE TO THE COMPLEXITIES OF THEIR ARMS WITH NO ULTRASOUND ASSIST TO MAP THEM. THIS IS LEADING TO LONGER TIME WITH A CATHETER.
Patient problems: Infiltration into Tissue
MAUDE report 8446381 ↗MalfunctionMar 15, 2019Image Display Error/Artifact
PER BIOMED: THE SCREEN SHOWS VERTICAL LINES ON HALF OF THE SCREEN BLOCKING VIEWING AREA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8425920 ↗MalfunctionMar 15, 2019Poor Quality Image
PER BIOMED: UNABLE TO VISUALIZE THE PICC POSITION DUE TO POOR IMAGE QUALITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8425918 ↗MalfunctionMar 15, 2019Display Difficult to Read
PER BIOMED: THERE ARE VERTICAL LINES ON SCREEN, THEY WILL NOT GO AWAY AFTER REBOOT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8425813 ↗MalfunctionFeb 1, 2019Power Problem; Noise, Audible
PER BIOMED: THE UNIT SHUTS DOWN WHEN UNPLUGGED. MAKES CLICKING NOISES WHILE RUNNING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8298109 ↗MalfunctionDec 31, 2018Defective Device
IT WAS REPORTED, PER BIOMED, THAT THE UNIT IS CONSISTENTLY FREEZING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8206245 ↗MalfunctionOct 9, 2018Poor Quality Image
CUSTOMER FACILITY REPORTED THAT PREVUE ULTRASOUND UNIT HAS A POOR IMAGE QUALITY.
Patient problems: No Patient Involvement
MAUDE report 7950151 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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