Site~Rite 8 Ultrasound System 9770600YRecalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System Console (Remanufactured) · 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 remanufactured Bard Site-Rite 8 ultrasound system is an imaging console used to find veins before needle placement. Its 332 reports mostly describe poor image quality, battery problems and the unit losing power or shutting off unexpectedly. The reports mention no deaths and no injuries. 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
- 330
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 00801741138287), received between Aug 9, 2018 and Jun 1, 2026 — classified as 330 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (96 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 Image96
- Battery Problem85
- Loss of Power68
- No Apparent Adverse Event67
- Unexpected Shutdown51
- Premature Discharge of Battery15
- Application Program Freezes or Fails to Launch14
- Defective Component12
Patient problems
- No Clinical Signs, Symptoms or Conditions157
- No Consequences Or Impact To Patient154
- No Known Impact Or Consequence To Patient68
Recent adverse event reports
The 25 most recent of 330 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Data Problem
IT WAS REPORTED THAT USER ADVISED THEY ARE NOT ABLE TO GET A CORRECT READING WHEN USING THE SENSOR FOR A PICC LINE. HAD THE USER TRY THE SENSOR ON ANOTHER ULTRASOUND, AND IT WORKED FINE. INACCURATE READINGS FOR MAGNETIC TIP. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350031 ↗MalfunctionFeb 25, 2026No Apparent Adverse Event; Unexpected Shutdown
IT WAS REPORTED THAT WHILE IT APPEARS TO BE CHARGING WITH NO CONTINUED ISSUES, WHEN LEFT ON, IT IS TURNING OFF RANDOMLY, EVEN WITH 100% CHARGE AND PLUGGED IN. I CHECKED THE BATTERY SWITCH AND RESET BUT CONTINUE TO HAVE THE SAME ISSUE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444426 ↗MalfunctionFeb 20, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BLURRED IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403092 ↗MalfunctionFeb 10, 2026Poor Quality Image
IT WAS REPORTED THERE IS A DEAD SPOT ON ALL IMAGES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306400 ↗MalfunctionJan 27, 2026Poor Quality Image
IT WAS REPORTED THE IMAGES ARE GRAINY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195899 ↗MalfunctionJan 27, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY THE CUSTOMER "IMAGE QUALITY IS BAD. HAD TO USE SONOSITE TO FIND THE VEIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193760 ↗MalfunctionJan 7, 2026Data Problem
IT WAS REPORTED PER RN, "WE ARE HAVING ISSUES WITH THE SAPIENS READING AND FOUR PICCS BEING MAL-POSITIONED (TOO LONG AND TOO SHORT) AND NEEDING TO BE PULLED BACK OVER THE LAST MONTH." THIS REPORT ADDRESSES ALL FOUR MAL-POSITIONED PICCS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23993071 ↗MalfunctionDec 4, 2025Device Dislodged or Dislocated; Data Problem; Device Dislodged or Dislocated; Data Problem
ADDITIONAL INFORMATION: NO PATIENT HARM OR REACTION. PICCS HAD TO BE REPOSITIONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719080 ↗MalfunctionDec 4, 2025Device Dislodged or Dislocated; Data Problem; Device Dislodged or Dislocated; Data Problem
ADDITIONAL INFORMATION RECEIVED: NO PATIENT HARM OR REACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23718952 ↗MalfunctionAug 12, 2025No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem
IT WAS REPORTED OF HAVING PROBLEMS WITH GETTING ACCURATE READINGS WHEN USING THE SHERLOCK SENSOR. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790528 ↗MalfunctionAug 12, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THERE ARE ARTIFACTS APPEARING ON THE RIGHT SIDE OF THE SCREEN. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790527 ↗MalfunctionJul 31, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED CUSTOMER IS EXPERIENCING POOR IMAGE QUALITY, STATING THERE IS A "CONED SHAPED HIGHLIGHTED AREA" ON THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676253 ↗MalfunctionJul 1, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED; UNIT HAS A MUCH GRAINIER IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22376663 ↗MalfunctionMay 1, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED OF ISSUES WITH IMAGES PAST 3CM DUE TO DARK IMAGES. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941810 ↗MalfunctionMar 26, 2025Defective Component; Application Program Freezes or Fails to Launch; Defective Component; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE UNIT IS INTERMITTENTLY FREEZING UP. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21702460 ↗MalfunctionJan 31, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED, POOR IMAGE QUALITY. THEY OTHER PROBES IN THE SR8 AND STILL IMAGE IS BAD. THE PROBES THEY TRIED ON THIS SR8 WORKED FINE ON OTHER SR8. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21288209 ↗MalfunctionJan 31, 2025Failure to Charge; Unexpected Shutdown; Failure to Charge; Unexpected Shutdown
IT WAS REPORTED PER RN, "THE RED BATTERY LINE ON THE SCREEN JUST STARTED TO GO ON, IT COUNTS DOWN TO 10 AND THEN SHUTS OFF. WE KEEP THE MONITOR PLUGGED IN OVERNIGHT. TRIED TURNING IT ON WHILE PLUGGED IN, AND THE SAME THING HAPPENS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284580 ↗MalfunctionJan 30, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED SR8 HAVING POOR IMAGING ISSUES. VERIFIED THEY HAVE SWAPPED PROBES AND ADJUSTED SETTINGS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277504 ↗MalfunctionJan 29, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY THE CUSTOMER, SR8 HAVING POOR IMAGING ISSUES. VERIFIED THEY HAVE SWAPPED PROBES, ADJUSTED SETTINGS, AND CURRENT SOFTWARE VERSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21266355 ↗MalfunctionJan 23, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY CLINICIANS THE IMAGE IS GRAINY AND DULL AFTER UPDATING SW VERSION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21219484 ↗MalfunctionDec 29, 2024No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem
IT WAS REPORTED THAT THE SHERLOCK IS NOT TRACKING PROPERLY RESULTING IN THE PATIENT RECEIVING A CXR TO VERIFY PICC PLACEMENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032705 ↗MalfunctionDec 5, 2024No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem
IT WAS REPORTED UNIT IS SHOWING A YELLOW ECG LINE BEFORE ANY KIND OF DEVICE IS TURNED ON. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854054 ↗MalfunctionNov 23, 2024No Apparent Adverse Event; Data Problem; No Apparent Adverse Event; Data Problem
IT WAS REPORTED PLACING PICC USING SENSOR AND SENSOR SHOWING PICC IS COMING IN FROM THE OPPOSITE SIDE. ALREADY SWAPPED SENSOR WITH NEW SENSOR AS WELL AS UPGRADED SOFTWARE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20766615 ↗MalfunctionNov 23, 2024Loose or Intermittent Connection; Application Program Freezes or Fails to Launch; Loose or Intermittent Connection; Application Program Freezes or Fails to Launch
IT WAS REPORTED UNIT IS GIVING EC205, UNIT IS ALSO FREEZING UP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20766575 ↗MalfunctionNov 20, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED, SCREEN FREEZING AND UNABLE TO GET IT TO UNFREEZE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20738417 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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