Site~Rite 8 Ultrasound System 9770602XRecalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System 20mm Pinpoint GT 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741138195), received between Oct 30, 2020 and May 28, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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.
Most reported problems
Device problems
- Crack1
- Defective Component1
- No Apparent Adverse Event1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2021Defective Component; No Apparent Adverse Event; Defective Component; No Apparent Adverse Event
FOUND DURING EVALUATION: THE PROBE¿S IMAGE HAS WHITE LINES COMING UP FROM THE BOTTOM OF THE SCREEN. THERE IS NO ERROR WHEN THE PROBE IS PLUGGED IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11900794 ↗MalfunctionOct 30, 2020Poor Quality Image; Crack; Poor Quality Image
PER BIOMED, THEY BELIEVE THERE IS A CRACKED CRYSTAL DUE TO THE LINES IN THE IMAGE AND POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10764670 ↗
Other Transducer, ultrasonic, diagnostic devices
- Site~Rite 8 Ultrasound System 9770603Bard Access Systems, Inc. · Transducer, ultrasonic, diagnostic620 reports
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- EPIQ Diagnostic Ultrasound System 989605488741Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic3 recalls165 reports
- bk3000, bk3500, bk5000, bkActiv 2300Bk Medical Aps · Transducer, Ultrasonic, Diagnostic6 recalls1 report
- Transducer L12-3 989605412072Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls1 report
- Transducer L15-7io 989605387852Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
- Transducer eL18-4 EMT 989605431531Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
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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