Site~Rite 8 Ultrasound System 9770600Recalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System Console · Class 2
All models of Site~Rite 8 Ultrasound System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Site~Rite 8 ultrasound system console appears in 639 adverse event reports, including 2 injuries and no deaths. Many reports describe hazy or unclear images, and others describe sudden shutdowns and frozen software. 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
- 629
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 629 adverse event reports that list this exact device (DI 00801741138263), received between Mar 2, 2018 and Sep 30, 2026 — classified as 2 injuries, 627 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (238 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 Image238
- No Apparent Adverse Event174
- Unexpected Shutdown114
- Application Program Freezes or Fails to Launch72
- Loss of Power43
- Defective Component39
- Battery Problem34
- Data Problem29
Patient problems
- No Clinical Signs, Symptoms or Conditions447
- No Consequences Or Impact To Patient162
- No Known Impact Or Consequence To Patient50
- No Information2
- Injury1
Recent adverse event reports
The 25 most recent of 629 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954460 ↗MalfunctionSep 2, 2026Break; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566058 ↗MalfunctionAug 19, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333391 ↗MalfunctionJul 29, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072946 ↗MalfunctionMay 5, 2026Premature Discharge of Battery; Erratic or Intermittent Display
IT WAS REPORTED UNIT IS GIVING BATTERY HEALTH MESSAGE. USERS ALSO STATE THE UNIT IS SHOWING A SCREEN THAT WENT BLURRY AND LOOKED "WEIRD" FOR A FEW SECONDS THEN WENT BACK TO NORMAL. THE SOFTWARE VERSION IS ALSO OUT OF DATE AT 2.3.1. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087503 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT THE CORDS ARE FREYED AND EXPOSING WIRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057672 ↗MalfunctionApr 6, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED, IMAGE QUALITY IS DETERIORATING BEYOND NORMAL CIRCUMSTANCE. SAID SW WAS RECENTLY UPDATED BUT DOESN'T KNOW THE VERSION. HAS ALREADY ADJUSTED SETTINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791906 ↗MalfunctionApr 2, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BLURRY DARK IMAGES. CUSTOMER ADVISED THEY PURCHASED A NEW PROBE, BUT THEY ARE STILL HAVING IMAGE QUALITY ISSUES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765529 ↗MalfunctionMar 31, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED POOR IMAGE QUALITY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750529 ↗MalfunctionMar 18, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED IMAGE ISSUES. CUSTOMER TRIED SEVERAL PROBES, AND A SOFTWARE UPDATE, BUT NOTHING HELPED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629779 ↗MalfunctionMar 18, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED UNIT HAS BLURRY IMAGES. USER HAS TRIED DIFFERENT PROBE AND HAD AN UPDATE, BUT THE IMAGES STAY AS THEY ARE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626910 ↗MalfunctionMar 9, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BLURRY IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547661 ↗MalfunctionFeb 26, 2026Unexpected Shutdown
IT WAS REPORTED UNIT SHUTS OFF WHEN UNPLUGGED FROM AC POWER EVEN THOUGH BATTERY IS AT 90%.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462493 ↗MalfunctionFeb 4, 2026Poor Quality Image
IT WAS REPORTED, UNIT IS GIVING BLURRY IMAGES. CUSTOMER HAS TRIED SEVERAL PROBES AND HAS UPDATED THE SOFTWARE TO NO AVAIL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258152 ↗MalfunctionJan 27, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED UNIT IS GIVING BLURRY IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195548 ↗MalfunctionDec 30, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE UNIT HAS SEVERE IMAGE DEGREDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923319 ↗MalfunctionDec 3, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMAGE QUALITY IS BAD, THEY HAVE TRIED DIFFERENT PROBES AND ARE GETTING THE SAME RESULTS. THEY HAVE CHANGED IMAGE SETTING WITH NO CHANGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706493 ↗MalfunctionNov 11, 2025Imprecision; No Apparent Adverse Event; Imprecision; No Apparent Adverse Event
IT WAS REPORTED THAT THE ONSCREEN NEEDLE GUIDE IS MISALIGNED AND REQUIRES CALIBRATION/REPAIR. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526420 ↗MalfunctionNov 11, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT POOR IMAGE/BLURRY CUSTOMER HAS TRIED SEVERAL PROBES ON THIS UNIT AND ALSO DONE COMPARISONS, THE ISSUE SEEMS TO STAY WITH THE SR8. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525807 ↗MalfunctionNov 4, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT IMAGES ARE VERY GRAINY. USER TRIED SEVERAL PROBES AND THE IMAGE STAYS THE SAME. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23472008 ↗MalfunctionOct 30, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMAGES ARE VERY GRAINY. TRIED SEVERAL PROBES, IMAGES DID NOT IMPROVE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423891 ↗MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGES HAVE POOR FOCUS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420416 ↗MalfunctionOct 29, 2025Product Quality Problem; Unexpected Shutdown; Product Quality Problem; Unexpected Shutdown
IT WAS REPORTED THAT THE UNIT IS FREEZING AND SHUTTING DOWN GIVING CODE EC111. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420415 ↗MalfunctionOct 21, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED OF ISSUES WITH IMAGE CLARITY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351109 ↗MalfunctionOct 21, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED, NEEDLES ARE HARD TO SEE WHEN INSERTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350480 ↗
Other System, imaging, pulsed echo, ultrasonic devices
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- 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
- Transducer S7-2t 989605440772Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic4 recalls1 report
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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