Site-Rite 9770501Recalls & reported problems
Bard Access Systems, Inc. · SITE-RITE 8 ULTRASOUND SYSTEM W/ PHASER, US · Class 2
Quick summary
This Site-Rite ultrasound imaging system from Bard Access Systems produces images through a handheld probe. The FDA database holds 547 reports for it, mostly describing battery problems, power loss and grainy or dark images, with 3 injuries and no deaths. 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
- 546
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 546 adverse event reports that list this exact device (DI 00801741098338), received between Jun 8, 2017 and Apr 13, 2026 — classified as 3 injuries, 543 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (146 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem146
- Loss of Power137
- Poor Quality Image118
- Defective Component65
- Unexpected Shutdown45
- No Apparent Adverse Event43
- Application Program Freezes or Fails to Launch24
- Break22
Patient problems
- No Consequences Or Impact To Patient256
- No Clinical Signs, Symptoms or Conditions194
- No Known Impact Or Consequence To Patient176
- No Information7
- Fistula1
- Hemorrhage/Blood Loss/Bleeding1
- Needle Stick/Puncture1
- No Code Available1
Recent adverse event reports
The 25 most recent of 546 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Poor Quality Image
IT WAS REPORTED UNIT IS GIVING DARK, SNOWY IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865566 ↗MalfunctionFeb 11, 2026Poor Quality Image
IT WAS REPORTED THE SCREEN ON THE SCANNER COMPLETELY DIMS OUT DURING USE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316521 ↗MalfunctionDec 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE QUALITY IS DEGRADED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866114 ↗MalfunctionDec 2, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED GT PROBE GIVING GRAINY IMAGING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696397 ↗MalfunctionNov 18, 2025Poor Quality Image; Product Quality Problem; Poor Quality Image; Product Quality Problem
IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING ISSUES WITH THE PROBE/IMAGE QUALITY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584794 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT THE CORD ON THE PROBE IS PULLING AWAY AT THE STRAIN RELIEF/EXPOSING WIRING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584396 ↗MalfunctionOct 30, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY A TM THAT THE IMAGE IS GRAINY AND NOT VERY GOOD. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423892 ↗MalfunctionOct 21, 2025Poor Quality Image; Poor Quality Image
FOUND DURING EVALUATION: THE IMAGE HAS A DROP GOING DOWN THE CENTER, THE PROBLEM IS TRACED TO A "SLIT MARK" ON THE FACE OF THE PROBE. THIS UNIT WILL HAVE TO BE RE-MANED TO ALLOW FOR A DETACHABLE PROBE, SINCE THE GT PROBE IS NO LONGER SUPPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352224 ↗MalfunctionOct 16, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THE PROBE IS CAUSING A SHADOW THAT RUNS HALFWAY DOWN THE LEFT SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310491 ↗MalfunctionAug 12, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE UNIT IS FREEZING WHILE USING THE ATTACHED PROBE. THE UNIT FROZE UP ON THE VERY FIRST PATIENT THAT THEY TRIED THIS UNIT ON. IT FREEZES UP WHILE USING THE ATTACHED PROBE. ADDITIONAL DETAILS 7/25/2025 - THE SCREEN FREEZES ON EVERY PATIENT AS WE ARE USING THE PROBE TO SCAN THE ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790460 ↗MalfunctionAug 7, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE ARE DROPOUTS IN THE IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738547 ↗MalfunctionJul 16, 2025No Apparent Adverse Event; Application Program Freezes or Fails to Launch; No Apparent Adverse Event; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE UNIT FREEZES UP DURING USE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523971 ↗MalfunctionMar 7, 2025Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT THE UNIT IS FREEZING DURING USE. THE ONLY WAY TO GET THE UNIT TO UNFREEZE IS TURN IT OFF AND BACK ON. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21553144 ↗MalfunctionFeb 25, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMAGES ARE SPOTTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459575 ↗MalfunctionNov 26, 2024Poor Quality Image; Poor Quality Image
FOUND DURING EVALUATION AT BD SERVICE FACILITY: THE UNIT WAS POWERED UP AND DISPLAYED A DARK LINE DOWN THE CENTER OF THE IMAGE. THE PROBE STRAIN RELIEF IS SEPARATING FROM THE PROBE BODY. THE ROOT CAUSE OF THE FAILURES WAS IDENTIFIED AS USE-RELATED DAMAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20781530 ↗MalfunctionNov 22, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE TRANSDUCER IS HAVING A GRAINY IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20764308 ↗MalfunctionSep 6, 2024Difficult or Delayed Activation; Difficult or Delayed Activation
IT WAS REPORTED BY THE CUSTOMER THERE IS A DELAY IN THE TIME THAT IT TAKES FOR THE TO PRODUCE AN IMAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20161720 ↗MalfunctionAug 27, 2024Break; Defective Component; Break; Defective Component
IT WAS REPORTED THAT THE PROBE CABLE IS FRAYED AND CAUSING WIRES TO BE EXPOSED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20082156 ↗MalfunctionAug 23, 2024Failure to Charge; Unexpected Shutdown; Failure to Charge; Unexpected Shutdown
IT WAS REPORTED THAT THE UNIT IS NOT HOLDING A CHARGE. THE CUSTOMER JUST CHANGED OUT THE BATTERY BUT THEY ARE STILL HAVING ISSUES. CALLER ADVISED WHEN THEY MOVE THE UNIT, BUT WILL SOMETIMES JUST SHUT DOWN IMMEDIATELY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20057529 ↗MalfunctionAug 23, 2024Poor Quality Image; Poor Quality Image
DURING EVALUATION OF THE RETURNED DEVICE, FOUND THE PROBE IS GIVING AN IMAGE WITH VERTICAL LINES ON THE LEFT SIDE OF THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20056581 ↗MalfunctionJul 9, 2024No Apparent Adverse Event; Application Program Freezes or Fails to Launch; No Apparent Adverse Event; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE SR8 FREEZES UP WHEN DOING SCANS. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19704169 ↗MalfunctionJun 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE IMAGES ON THE SR8 ARE NOT CLEAR. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19610938 ↗MalfunctionJun 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED A BROKEN STRAIN RELIEF ON HARDWIRED PROBE CABLE, IMAGE QUALITY ISSUES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19610933 ↗MalfunctionJun 14, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CUSTOMER COMPLAINS OF POOR IMAGE QUALITY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19538685 ↗MalfunctionApr 25, 2024Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE PROBE ON SR8 IS CAUSING IMAGES TO BE FUZZY AND VERTICAL LINES ARE APPEARING ON IMAGES. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19188716 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.