Site~Rite 8 Ultrasound System 9770603Recalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 20mm Cue Linear Probe · 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 probe appears in 639 adverse event reports, with no deaths and no injuries. Most reports describe poor image quality and parts breaking. 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
- 620
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 620 adverse event reports that list this exact device (DI 00801741138218), received between May 16, 2019 and Sep 22, 2026 — classified as 620 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (330 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 Image330
- Break206
- Defective Component143
- No Apparent Adverse Event67
- No Display/Image12
- Imprecision10
- Product Quality Problem6
- Image Display Error/Artifact5
Patient problems
- No Clinical Signs, Symptoms or Conditions592
- No Consequences Or Impact To Patient29
- No Known Impact Or Consequence To Patient7
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 620 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Poor Quality Image; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861502 ↗MalfunctionMay 22, 2026Poor Quality Image
IT WAS REPORTED THAT SYSTEM WAS DARK BARELY ANY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256507 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT DAMAGED STRAIN RELIEF. NO FURTHER INFORMATION PROVIDED. 1 MAY 2026: DURING EVALUATION IT WAS FOUND THAT WERE WIRES EXPOSED FROM THE CABLE DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25208008 ↗MalfunctionMay 18, 2026Poor Quality Image
T WAS REPORTED THAT SOME OF THE CRYSTALS ARE BAD, CAUSING DARK SPOTS ON SCREEN WHEN IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205258 ↗MalfunctionMay 13, 2026Poor Quality Image
IT WAS REPORTED THAT PROBE HEAD HAS DAMAGE CAUSING ARTIFACTS AND LINES ON THE IMAGES. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162879 ↗MalfunctionMay 12, 2026Poor Quality Image
IT WAS REPORTED BY BIOMED THERE ARE ARTIFACTS ON ALL IMAGES. NO PATIENT IMPACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155988 ↗MalfunctionMay 11, 2026Poor Quality Image
IT WAS REPORTED POOR IMAGE QUALITY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135335 ↗MalfunctionMay 1, 2026Poor Quality Image
IT WAS REPORTED POOR IMAGE QUALITY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059745 ↗MalfunctionApr 30, 2026Poor Quality Image
IT WAS REPORTED THE TRANSDUCER IS NOT WORKING AND HAVING PROBLEMS WITH THE IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044027 ↗MalfunctionApr 28, 2026Poor Quality Image
IT WAS REPORTED IMAGES ARE NOT CLEAR. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017598 ↗MalfunctionApr 27, 2026Poor Quality Image
IT WAS REPORTED THAT THE PROBE IMAGE HAS A LARGE BLACK CONE SHAPED ON ALL IMAGES. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000139 ↗MalfunctionApr 13, 2026Poor Quality Image
IT WAS REPORTED IMAGES ARE VERY DARK AND GRAINY. VERIFIED THEY'VE TRIED ADJUSTING FILTER SETTINGS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866338 ↗MalfunctionApr 13, 2026Break
IT WAS REPORTED EXPOSED WIRES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865746 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT CORD IS PULLING AWAY AT THE STRAIN RELIEF/EXPOSING WIRING. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845883 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT CORD HAS PULLED COMPLETELY AWAY AT THE STRAIN RELIEF AND HAS EXPOSED WIRING. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839918 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT CORD IS PULLING AWAY AT THE STRAIN RELIEF/EXPOSING WIRING. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839917 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT CORD HAS PULLED AWAY AT THE STRAIN RELIEF/EXPOSING WIRING. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792777 ↗MalfunctionApr 6, 2026Poor Quality Image
IT WAS REPORTED THAT PROBE HAS IMAGING DROP OUTS OR AREAS WHERE THERE ARE SPOTS OR SHADOWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791165 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED EXPOSED WIRES BY STRAIN RELIEF. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24749957 ↗MalfunctionMar 24, 2026Break
IT WAS REPORTED WIRES EXPOSED ON CORD. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676902 ↗MalfunctionMar 23, 2026Image Orientation Incorrect; Poor Quality Image
IT WAS REPORTED THAT CUSTOMER IS HAVING NOISY IMAGES WHEN USING PROBE. ADVISED HIM TO TRY TESTING THE VARIOUS FILTERS AND SENDING OUT UPGRADE DRIVE. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664964 ↗MalfunctionMar 18, 2026Poor Quality Image
IT WAS REPORTED BUBBLE/AIR POCKET IN THE HEAD OF THE PROBE CAUSE BLACK SPOTS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629943 ↗MalfunctionMar 11, 2026Poor Quality Image
IT WAS REPORTED POOR IMAGE QUALITY/DARK IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575048 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED EXPOSED WIRES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547968 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED EXPOSED WIRING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489412 ↗
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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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