Site~Rite 8 Ultrasound System 9770603RRecalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 20mm Cue Linear Probe (Refurbished) · 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 Site~Rite 8 ultrasound system's Cue linear probe is a refurbished transducer used to produce ultrasound images. Most of the 63 reports describe image quality problems, such as dark lines, shadows, or only part of the image showing, plus physical damage like cracked crystals, a cord pulling away and exposing wiring, and a damaged housing. None of the reports describe an injury or death. 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
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00801741155383), received between Aug 12, 2020 and Apr 1, 2026 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (39 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 Image39
- Break17
- No Apparent Adverse Event10
- Defective Component7
- No Display/Image3
- Image Display Error/Artifact1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions59
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2026Break
IT WAS REPORTED WIRES EXPOSED BY STRAIN RELIEF. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753254 ↗MalfunctionMar 30, 2026Poor Quality Image
IT WAS REPORTED HOUSING IS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED. 03/24/2026- IT WAS FOUND DURING AN INVESTIGATION THE PROBE HAS A BLACK LINE IN THE MIDDLE OF THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713394 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THE CORD HAS PULLED AWAY AT THE STRAIN RELIEF EXPOSING WIRING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428718 ↗MalfunctionFeb 4, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED, POOR IMAGES/HALF OF THE IMAGE IS DISPLAYING ON THE SCREEN WHEN IN USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258150 ↗MalfunctionJan 27, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED SHADOWS ARE SHOWING UP ON IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195546 ↗MalfunctionJan 27, 2026Poor Quality Image
IT WAS REPORTED THERE IS A BLACK LINE THAT RUNS DOWN JUST RIGHT OF CENTER OF THE IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195529 ↗MalfunctionDec 22, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED OF INABILITY TO SEE IMAGES WITH THE PROBE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865302 ↗MalfunctionDec 2, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE ARE TWO LARGE BLACK LINES THAT APPEAR DOWN THE FRONT OF THE SCREEN WHEN USING PROBE. TRIED SWITCHING IT WITH THE PROBE FROM THE MACHINE AND THAT ONE WORKS PERFECTLY FINE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700063 ↗MalfunctionDec 2, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGES ARE NOT CLEAR. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698743 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED STRAIN RELIEF IS CRACKED, YOU CAN SEE THE WIRES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23353116 ↗MalfunctionSep 10, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE PROBE IS ONLY SHOWING HALF OF THE IMAGE. TRIED PROBE ON ANOTHER SR8, ISSUE FOLLOWED THE PROBE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23016105 ↗MalfunctionSep 3, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED BY THE CUSTOMER THERE IS MAJOR DROP OUT ON THE LEFT SIDE OF THE IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22953236 ↗MalfunctionSep 2, 2025Break; Break
IT WAS REPORTED THAT THE STRAIN RELIEF HAS PULLED COMPLETELY AWAY, EXPOSING WIRING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949040 ↗MalfunctionSep 2, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE PROBE IS NOT PROPERLY CAPTURING THE IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949037 ↗MalfunctionAug 27, 2025Break; Break
IT WAS REPORTED BY THE CUSTOMER, DAMAGED STRAIN RELIEF EXPOSING CORDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903797 ↗MalfunctionAug 21, 2025Break; Break
IT WAS REPORTED THAT THE CORD IS DAMAGED AND WIRES ARE EXPOSED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22862696 ↗MalfunctionAug 12, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE PROBE IS HAVING IMAGING ISSUES. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790520 ↗MalfunctionAug 6, 2025Break; Break
IT WAS REPORTED THAT WIRES ARE EXPOSED FROM THE PROBE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22734398 ↗MalfunctionJul 16, 2025Break; Break
IT WAS REPORTED CORD IS PULLING AWAY AT THE STRAIN RELIEF, WIRING IS EXPOSED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523148 ↗MalfunctionJul 1, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE PROBE IS GIVING DROP OUT ON ALL IMAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378353 ↗MalfunctionMay 29, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE PROBE NO LONGER ACCURATE AFTER BEING DROPPED ON FLOOR. 15 MAY 2025: EVALUATION FOUND THE PROBE HAS DROPOUTS ON THE RIGHT SIDE OF THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22111045 ↗MalfunctionMay 7, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMAGES ARE VERY BLURRY. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21978990 ↗MalfunctionFeb 12, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED, STRAIN RELIEF PULLED FROM CONNECTOR HOUSING. UNIT IS ALSO HAVING ISSUES PRODUCING GRAINY IMAGES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21365497 ↗MalfunctionFeb 6, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE UNIT IS SHOWING A LONG DARK SPOT IN THE IMAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329487 ↗MalfunctionFeb 6, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY A TM THAT 3 LINES ARE OBSERVED WHEN ATTEMPTING TO UTILIZE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329371 ↗
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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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