BD SiteRite 9 Ultrasound System 9770803Recalls & reported problems
Bard Access Systems, Inc. · BD SiteRite 9 Cue Linear Probe · Class 2
All models of BD SiteRite 9 Ultrasound System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a BD SiteRite 9 linear ultrasound probe. Most of the 83 reports describe poor image quality, such as blurry images, lag, shadows or distortion, and some describe exposed wires or cords pulling loose. There are 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
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00801741226274), received between Dec 1, 2023 and Sep 30, 2026 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (69 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 Image69
- Defective Component20
- No Apparent Adverse Event14
- Product Quality Problem7
- Break2
- Difficult or Delayed Activation1
- Loose or Intermittent Connection1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions79
Recent adverse event reports
The 25 most recent of 79 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 50954902 ↗MalfunctionSep 23, 2026Poor Quality Image
It was reported the Probe has gone black down the center and there is wear on the strain relief. No patient impact. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870558 ↗MalfunctionJul 20, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED PROBE IMAGE DISTORTED, GREYED OUT. POOR IMAGE QUALITY. FAILING PROBE ASSESSMENT TEST AT TIMES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25875630 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED CORD IS PULLING AWAY AT THE STRAIN RELIEF, EXPOSING WIRING. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155991 ↗MalfunctionApr 6, 2026Difficult or Delayed Activation
IT WAS REPORTED THE DEVICE IS LAGGING, AND "GOING TO THE LEFT WHEN CENTERED". NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794111 ↗MalfunctionApr 6, 2026Poor Quality Image
IT WAS REPORTED THAT CUSTOMER IS EXPERIENCING DROP OUT ON IMAGES. USED ON A DIFFERENT SCANNER, ISSUE FOLLOWED THE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790423 ↗MalfunctionMar 31, 2026Poor Quality Image
IT WAS REPORTED DAMAGED PROBE, AS IT DOES THE SHIMMERING EFFECT ON THE BOTTOM OF THE IMAGE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750530 ↗MalfunctionMar 24, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED PROBE IS SHOWING DAMAGE TO THE CRYSTALS ON THE PROBE, CAUSING IT TO HAVE POOR IMAGE QUALITY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682510 ↗MalfunctionMar 24, 2026Poor Quality Image
IT WAS REPORTED THAT THERE IS A SHADOW ON ALL IMAGES/PROBE IS FAILING ASSESSMENT TEST. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681483 ↗MalfunctionMar 18, 2026Poor Quality Image
IT WAS REPORTED BLACK LINE ON IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634675 ↗MalfunctionMar 18, 2026Poor Quality Image
IT WAS REPORTED BLACK LINES ON IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24626909 ↗MalfunctionFeb 27, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT PROBE THAT HAS A POOR IMAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471322 ↗MalfunctionFeb 24, 2026Product Quality Problem
IT WAS REPORTED PROBE IS FAILING ASSESSMENT TEST. THE FIRST PIXEL ON THE OUTSIDE. 24 FEB 2026 FOUND DURING EVALUATION: THE PROBE HAS A BLACK LINE IN THE LEFT OF THE IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24436427 ↗MalfunctionFeb 23, 2026Poor Quality Image
IT WAS REPORTED THE PROBE HAS SHADOWING ON IMAGES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413376 ↗MalfunctionFeb 10, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED, LAGGING AND POOR IMAGE QUALITY. VERIFIED SW VERSION AND CUSTOMER TRIED THIS PROBE ON DIFFERENT SYSTEM. ISSUE FOLLOWS THE PROBE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306406 ↗MalfunctionFeb 10, 2026No Display/Image
IT WAS REPORTED, HALF OF THE IMAGE IS BLANK WHEN USING THIS PROBE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304580 ↗MalfunctionJan 27, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THE SITE RITE 9 PROBE IS PRODUCING LINES AT THE BOTTOM OF THE SCREEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195549 ↗MalfunctionJan 27, 2026Poor Quality Image; Product Quality Problem
IT WAS REPORTED THE PROBE IS HAVING IMAGING ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193231 ↗MalfunctionJan 7, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED BY THE CUSTOMER PROBE IS HAVING ISSUES VISUALIZING NEEDLES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23993120 ↗MalfunctionDec 3, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE IS A SHADOW DOWN THE MIDDLE OF THE IMAGE TRANSDUCER. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706484 ↗MalfunctionNov 11, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED CRYSTALS ARE BROKEN IN THE PROBE WHICH IS CAUSING A BLACK LINE WHILE USING THE PROBE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523715 ↗MalfunctionOct 30, 2025Poor Quality Image; Product Quality Problem; Poor Quality Image; Product Quality Problem
IT WAS REPORTED THAT THE PROBE IS FAILING ASSESSMENT TEST/RIGHT SIDE OF THE PROBE HAS SEVERAL PIXELS OUT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425723 ↗MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGES ARE NOT CLEAR AND THE PROBE FAILS THE ASSESSMENT TEST. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23418802 ↗MalfunctionOct 29, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGES ARE NOT CLEAR AND THE PROBE FAILS ASSESSMENT TEST. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23418801 ↗MalfunctionOct 21, 2025Poor Quality Image; Product Quality Problem; Poor Quality Image; Product Quality Problem
IT WAS REPORTED THAT THERE IS A LARGE DARK SPOT ON THE IMAGES. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351555 ↗
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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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