Site~Rite 8 Ultrasound System 9770600XRecalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System Console (Refurbished) · Class 2
All models of Site~Rite 8 Ultrasound System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741138270), received between Jun 20, 2019 and Sep 21, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image4
- Image Display Error/Artifact2
- No Apparent Adverse Event2
- Application Program Freezes or Fails to Launch1
- Data Problem1
- Imprecision1
- No Display/Image1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848282 ↗MalfunctionMay 5, 2026Imprecision
IT IS REPORTED THAT A SITERITE 8 HAS A NEEDLE SHOWING UP ON THE FAR LEFT SIDE OF THE SCREEN. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25088908 ↗MalfunctionDec 8, 2022Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
PER BIOMED - IT LOOKS LIKE IT¿S RAINING FROM THE MIDDLE TO THE BOTTOM OF THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15946290 ↗MalfunctionSep 8, 2022Data Problem; Data Problem
PER TM ,NIT WORKED FINE AND THEN RECENTLY BEGAN GIVING INCORRECT P-WAVES¿SHOWED OPTIMAL P-WAVES ABOUT 5 CM FROM SVC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15386732 ↗MalfunctionJun 15, 2022Poor Quality Image; Poor Quality Image
CONTACT STATING THAT UNIT IS HAVING IMAGE ISSUES AS THE IMAGES ARE NOT CLEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14705938 ↗MalfunctionApr 27, 2022Poor Quality Image; Poor Quality Image
ULTRASOUND WENT GRAINY, LIKE CLEAR, AND THEN TURNED IT ON AGAIN AND GRAINY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14222779 ↗MalfunctionSep 2, 2021Poor Quality Image; Poor Quality Image
PER TM - UNIT IS GIVING A VERY GRAINY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12416291 ↗MalfunctionMar 26, 2021No Apparent Adverse Event; Application Program Freezes or Fails to Launch; No Apparent Adverse Event; Application Program Freezes or Fails to Launch
PER TM - THE UNIT FROZE UP AND HE HAD TO REBOOT. THEY REPORT THAT IT IS "GLITCHING/FREEZING AND CUTTING OUT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574519 ↗MalfunctionNov 20, 2020No Display/Image; Image Display Error/Artifact; No Display/Image
FOUND DURING EVALUATION: THERE IS A BLACK LINE IN THE MIDDLE OF THE ULTRASOUND IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10880124 ↗MalfunctionJun 20, 2019Image Display Error/Artifact
UNIT WAS REPORTED TO BE PERIODICALLY FREEZING AT LEAST ONCE A WEEK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8717777 ↗
Other System, imaging, pulsed echo, ultrasonic devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
- Site~Rite 8 Ultrasound System 9770600Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic629 reports
- Site-Rite 9770501Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic546 reports
- Transducer X8-2t 989605455171Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic8 recalls19 reports
- Transducer C10-3v 989605409562Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic7 recalls0 reports
- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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