Site~Rite 8 Ultrasound System 9770601XRecalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System 32mm 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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741138300), received between Jun 6, 2019 and May 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Poor Quality Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Break
IT WAS REPORTED PROBE HAS EXPOSED WIRES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25338321 ↗MalfunctionOct 20, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED POOR IMAGE QUALITY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490054 ↗MalfunctionAug 5, 2021Break; Break
PER TM - CORD PULLING AWAY FROM STRAIN RELIEF. 07/27/2021 EVALUATION OF THE SAMPLE FOUND THE WIRES TO BE EXPOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12281148 ↗MalfunctionJun 6, 2019Poor Quality Image
PER BIOMED, THE PROBE SHOWS A PARTIAL SCREEN WHEN SCANNING, THE NURSE NEEDS TO APPLY PRESSURE TO SEE VEIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8677159 ↗
Other Transducer, ultrasonic, diagnostic devices
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- Transducer L15-7io 989605387852Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
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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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