Site~Rite 8 Ultrasound System 9770601YRecalls & reported problems
Bard Access Systems, Inc. · Site~Rite 8 Ultrasound System 32mm Linear Probe (Remanufactured) · 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741138317), received between Nov 13, 2018 and Mar 31, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (4 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.
Most reported problems
Device problems
- Poor Quality Image4
- Break2
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2023Break; Break
IT WAS REPORTED THE CORD IS PULLING AWAY/BREAKING AT THE STRAIN RELIEF, EXPOSING WIRES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16657142 ↗MalfunctionOct 22, 2021Poor Quality Image; Poor Quality Image
CHIPPED ON THE TOP AND THERE IS A ¿V¿ ON THE SCREEN THAT FOLLOWS PROBE MOVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12681162 ↗MalfunctionMay 28, 2021Poor Quality Image; Poor Quality Image
OBSERVATION FOUND DURING EVALUATION: THERE ARE DARK VERTICAL LINES IN THE ULTRASOUND IMAGE DUE TO AN INTERNAL FAILURE WITHIN THE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11900632 ↗MalfunctionFeb 19, 2021Poor Quality Image
PER BIOMED - VERY DARK IMAGES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11350939 ↗MalfunctionJun 9, 2020Break; Break
PER BIOMED, PROBE STRAIN RELIEF DAMAGED, WITH EXPOSED WIRES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10135840 ↗MalfunctionNov 13, 2018Poor Quality Image; No Display/Image; Poor Quality Image
PICC RN REPORTED SYSTEM'S ULTRASOUND IMAGE IS VERY DARK.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8067241 ↗
Other Transducer, ultrasonic, diagnostic devices
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- Transducer X7-2t 989605414122Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic6 recalls21 reports
- 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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