Site-Rite 9770001Recalls & reported problems
Bard Access Systems, Inc. · SITE-RITE 6 PROBE · Class 2
All models of Site-Rite (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741125744), received between Feb 22, 2018 and May 21, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image3
- No Display/Image2
- Crack1
- Device Operates Differently Than Expected1
- Display or Visual Feedback Problem1
- Image Display Error/Artifact1
- Signal Artifact/Noise1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE UNIT IS PRODUCING GRAINY IMAGES/DISPLAY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360998 ↗MalfunctionJan 12, 2019No Display/Image
IT WAS REPORTED, THAT THE IMAGE FROM THE PROBE IS DIFFICULT TO SEE WHEN PLACING A PICC.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8242929 ↗MalfunctionJan 12, 2019No Display/Image
IT WAS REPORTED, THAT THE UNIT'S PROBE SHOWS A DARK SHADOW ON THE ULTRASOUND SCREEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8242926 ↗MalfunctionDec 7, 2018Poor Quality Image
BIOMED REPORTED SYSTEM HAS POOR ULTRASOUND IMAGE QUALITY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8143795 ↗MalfunctionNov 20, 2018Image Display Error/Artifact
PER BIOMED: THE PROBE IS CASTING SHADOWS IN THE IMAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8092456 ↗MalfunctionSep 7, 2018Crack; Poor Quality Image
BIOMED REPORTED THAT SITE RITE 6 PROBE (B)(4) DISPLAYS A POOR QUALITY IMAGE. PROBE IS PHYSICALLY CRACKED AND DAMAGED AND BIOMED FEELS THAT IS CAUSING THE POOR IMAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7858221 ↗MalfunctionMar 14, 2018Signal Artifact/Noise; Display or Visual Feedback Problem
PER BIOMED: SITE RITE 6 PROBE 10145405 IS CAUSING SOME BLANK SPOTS, ARTIFACT IN THE IMAGE. POSSIBLE DAMAGED CRYSTALS IN THE PROBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7340080 ↗MalfunctionFeb 22, 2018Device Operates Differently Than Expected
IT WAS REPORTED BY THE FACILITY THAT THERE IS A "DROP-OUT" ON THE IMAGE WITH THE SITE RITE 6 PROBE (SN:(B)(4)) WITH BLACK LINES DOWN THE SCREEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7289846 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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