Site-Rite 9770090Recalls & reported problems
Bard Access Systems, Inc. · SITE-RITE PREVUE ULTRASOUND SYSTEM · Class 2
All models of Site-Rite (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741091056), received between Apr 3, 2018 and Jul 1, 2020 — classified as 12 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (5 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
- No Display/Image5
- Loss of Power2
- Poor Quality Image2
- Battery Problem1
- Failure to Align1
- Failure to Charge1
- Image Display Error/Artifact1
- Intermittent Continuity1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient4
- No Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2020No Display/Image; No Display/Image
DURING EVALUATION, IT WAS FOUND THE SYSTEM DISPLAYS DARK VERTICAL LINES IN THE PROBE IMAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10218692 ↗MalfunctionMay 28, 2020Loss of Power; Battery Problem; Loss of Power; Battery Problem
PER BIOMED THE SCANNER IS NOT HOLDING A CHARGE/ABRUPT SHUT OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10096357 ↗MalfunctionFeb 13, 2020Poor Quality Image; Poor Quality Image
PER BIOMED - STAFF IS COMPLAINING THAT THE IMAGE IS TOO DARK TO SEE STRUCTURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9707909 ↗MalfunctionDec 13, 2019No Display/Image; No Display/Image
PER BIOMED - UNIT HAS AN ARTIFACT DOWN THE MIDDLE OF THE SCREEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9467639 ↗MalfunctionJul 23, 2019No Display/Image
ONLY HALF THE SCREEN IS VISIBLE. YOU CAN NOT SEE ONE HALF OF THE SCREEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8819880 ↗MalfunctionJul 11, 2019No Display/Image
PER TM - SCREEN HAS GONE BLANK ON THIS UNIT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8781771 ↗MalfunctionJun 14, 2019Failure to Charge; Loss of Power
UNIT WILL NOT HOLD A CHARGE/DOES NOT CHARGE. THE DEVICE IMMEDIATELY SHUTS DOWN ONCE THE UNIT IS UNPLUGGED FROM AC POWER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8700335 ↗MalfunctionMay 23, 2019Failure to Align
PER BIOMED FROM USER THE PROBE IS OUT OF ALIGNMENT WHILE USING GEL CAPS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8637710 ↗MalfunctionOct 10, 2018Image Display Error/Artifact
BIOMED REPORTED THE PREVUE ULTRASOUND HAS POOR IMAGE QUALITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7953670 ↗MalfunctionAug 22, 2018Poor Quality Image
IT WAS REPORTED BY BIOMED STATING THAT THE SR PREVUE HAS "POOR IMAGE QUALITY. CAN'T READ 'PREVUE' WHEN IT BOOTS UP AND FADES IN AND OUT."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7807799 ↗MalfunctionAug 9, 2018No Display/Image
SALES REP REPORTED HALF OF THE SCREEN REMAINS BLACK.
Patient problems: No Information
MAUDE report 7768183 ↗MalfunctionApr 3, 2018Intermittent Continuity; Operating System Becomes Nonfunctional
CUSTOMER REPORTED SYSTEM FREEZES INTERMITTENTLY. CLEARS WITH REBOOT, THEN FREEZES AGAIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7394484 ↗
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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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