Site-Rite 9770501RRecalls & reported problems
Bard Access Systems, Inc. · SITE-RITE 8 ULTRASOUND SYSTEM W/ PHASER, US Refurbished · Class 2
All models of Site-Rite (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741104138), received between Dec 21, 2018 and Aug 29, 2024 — classified as 21 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.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image8
- Loss of Power5
- Application Program Freezes or Fails to Launch3
- Battery Problem3
- Defective Component2
- Break1
- Data Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2024Defective Component; Application Program Freezes or Fails to Launch; Defective Component; Application Program Freezes or Fails to Launch
IT WAS REPORTED BY THE CUSTOMER, UNIT IS FREEZING UP MID-PROCEDURE. THEY WOULD HAVE TO RESTART IT COUPLE TIMES FOR IT TO STOP FREEZING. UNIT HAS NOW CUT OFF RANDOMLY SEVERAL TIMES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20098237 ↗MalfunctionMay 22, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SR8 IS PRODUCING GRAINY IMAGES. VERIFIED THEY'VE TRIED ADJUSTING THE CONTRAST AND FILTER SETTINGS BUT THE ISSUE PERSISTS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372223 ↗MalfunctionMar 29, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE UNIT IS FREEZING UP MID-PROCEDURE AND GIVING EC111. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19005245 ↗MalfunctionJun 15, 2023Poor Quality Image; Poor Quality Image
IT WAS FOUND DURING EVALUATION AT BD SERVICE CENTER: THE IMAGE PRODUCED BY THE PROBE HAS A DARK LINE IN THE MIDDLE DUE TO A TRANSDUCER ELEMENT FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17140805 ↗MalfunctionJun 13, 2023Break; Break
IT WAS FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE PROBE HAS THE WIRES EXPOSED DUE TO USE-RELATED DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17118426 ↗MalfunctionApr 7, 2023Poor Quality Image; Poor Quality Image
OBSERVATION FOUND DURING AN EVALUATION: THE PROBE HAS A DROP OUT IN THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16701352 ↗MalfunctionFeb 2, 2022Poor Quality Image; Poor Quality Image
PER TM: UNIT HAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13425464 ↗MalfunctionJun 16, 2021No Apparent Adverse Event; Application Program Freezes or Fails to Launch; No Apparent Adverse Event; Application Program Freezes or Fails to Launch
PER TM - UNIT IS FREEZING ON THE MAIN SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12013427 ↗MalfunctionJun 9, 2021Premature Discharge of Battery; Premature Discharge of Battery
PER BIOMED - BATTERY WILL NOT HOLD IT'S CHARGE. IT IS NOT GIVING ANY MESSAGE. IT WILL BE 100% CHARGED, BUT WHEN THE NURSES UNPLUG IT AND TAKE IT TO SOMEONE'S ROOM, THEY HAVE TO PLUG THE BATTERY IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11967334 ↗MalfunctionApr 9, 2021Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
FOUND DURING EVALUATION: THERE ARE SCRATCHES ON THE PROBES PAD CAUSING DARK VERTICAL LINES IN THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641767 ↗MalfunctionApr 2, 2021Poor Quality Image; Poor Quality Image
PER BIOMED - SCREEN HAS A RAIN EFFECT AND ALSO HAS A GREEN RING ON THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11609583 ↗MalfunctionOct 1, 2020Poor Quality Image; Poor Quality Image
PER TM - THE IMAGE QUALITY HAS DEGRADED OVER THE LIFE OF THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10613504 ↗MalfunctionSep 3, 2020Loss of Power; Loss of Power
THE SCANNER SHUTS DOWN PREMATURELY WHEN AC POWER IS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10490491 ↗MalfunctionAug 20, 2020Data Problem; Data Problem
PER BIOMED, BATTERY LIGHT IS FLASHING WHEN PLUGGED IN. STATUS OF BATTERY INDICATES EITHER 8 OR 73% WHETHER PLUGGED OR UNPLUGGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10431234 ↗MalfunctionJun 10, 2020Battery Problem; Battery Problem
PER (B)(6), BATTERY WILL NOT HOLD A CHARGE. SAMPLE EVALUATION CONFIRMED SCANNER SHUTS DOWN PREMATURELY WHEN AC POWER IS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10137412 ↗MalfunctionApr 8, 2020Loss of Power; Loss of Power
PER PICC TEAM - THE SCANNER HAD AN ABRUPT SHUT OFF WHEN THE BATTERY SHOWED 70%.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9935553 ↗MalfunctionMar 12, 2020Poor Quality Image; Poor Quality Image
PER BIOMED - THE SCANNERS PICTURE IS HAS SNOW EFFECT TOWARDS BOTTOM OF SCREEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9823735 ↗MalfunctionMar 5, 2020Loss of Power; Loss of Power
PER BIOMED - THE SCANNER IS NOT HOLDING A CHARGE THE NURSES CLAIM THAT IF IT'S NOT PLUGGED IN THE UNIT SHUTS OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9794033 ↗MalfunctionSep 27, 2019Loss of Power; Battery Problem; Loss of Power; Battery Problem
PER TM, UNIT WILL NOT HOLD A CHARGE. SHUTS OFF AT 80% AFTER UNPLUGGING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9131807 ↗MalfunctionSep 26, 2019Loss of Power; Battery Problem; Loss of Power; Battery Problem
PER BIOMED: THE BATTERY WILL NOT HOLD A CHARGE. SHUTS DOWN ALMOST AS SOON AS IT'S UNPLUGGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9126943 ↗MalfunctionDec 21, 2018No Display/Image
IT WAS REPORTED THAT THE UNIT MONITOR IS DISPLAYING POOR IMAGE QUALITY AND USERS ARE UNABLE TO SEE VEIN STRUCTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8190885 ↗
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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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