Site-Rite 9770168Recalls & reported problems
Bard Access Systems, Inc. · SITE-RITE VISION II 40MM LINEAR PROBE · Class 2
Data updated Oct 13, 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 00801741125331), received between May 4, 2018 and Jan 17, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Align1
- No Display/Image1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2019No Display/Image
IT WAS REPORTED THAT THE PROBE IS NOT GIVING A CLEAR IMAGE. MOVING THE PROBE DOES PRODUCE A BETTER IMAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8256964 ↗MalfunctionMay 4, 2018Failure to Align
CUSTOMER REPORTED VISION II PROBE IS OFF CENTER WHEN SCANNING FOR A VEIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7488589 ↗
Other Transducer, ultrasonic, diagnostic devices
- Site~Rite 8 Ultrasound System 9770603Bard Access Systems, Inc. · Transducer, ultrasonic, diagnostic620 reports
- ULTRASONIC PROBE UM-S20-17SOlympus Medical Systems Corp. · Transducer, ultrasonic, diagnostic2 deaths344 reports
- 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 eL18-4 EMT 989605431531Philips Ultrasound LLC · Transducer, ultrasonic, diagnostic5 recalls0 reports
- Transducer L15-7io 989605387852Philips 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page