Site~Rite 8 Ultrasound SystemRecalls & reported problems across all models
Bard Access Systems, Inc. · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,965
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 11 models of Site~Rite 8 Ultrasound System by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,965 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2018 and Sep 30, 2026 — classified as 2 injuries, 1,963 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (931 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Site~Rite 8 Ultrasound System problems
Device problems
- Poor Quality Image931
- No Apparent Adverse Event359
- Break259
- Defective Component239
- Unexpected Shutdown168
- Battery Problem119
- Loss of Power111
- Application Program Freezes or Fails to Launch96
Patient problems
- No Clinical Signs, Symptoms or Conditions1,453
- No Consequences Or Impact To Patient437
- No Known Impact Or Consequence To Patient177
- Insufficient Information3
- No Information2
- No Patient Involvement2
- Injury1
Site~Rite 8 Ultrasound System models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Site~Rite 8 Ultrasound System 9770600System, imaging, pulsed echo, ultrasonic629 reports
- Site~Rite 8 Ultrasound System 9770603Transducer, ultrasonic, diagnostic620 reports
- Site~Rite 8 Ultrasound System 9770600YSystem, imaging, pulsed echo, ultrasonic330 reports
- Site~Rite 8 Ultrasound System 9770602Transducer, ultrasonic, diagnostic122 reports
- Site~Rite 8 Ultrasound System 9770601Transducer, ultrasonic, diagnostic103 reports
- Site~Rite 8 Ultrasound System 9770602YTransducer, ultrasonic, diagnostic78 reports
- Site~Rite 8 Ultrasound System 9770603RTransducer, ultrasonic, diagnostic61 reports
- Site~Rite 8 Ultrasound System 9770600XSystem, imaging, pulsed echo, ultrasonic10 reports
- Site~Rite 8 Ultrasound System 9770601YTransducer, ultrasonic, diagnostic6 reports
- Site~Rite 8 Ultrasound System 9770601XTransducer, ultrasonic, diagnostic4 reports
- Site~Rite 8 Ultrasound System 9770602XTransducer, ultrasonic, diagnostic2 reports
Recent Site~Rite 8 Ultrasound System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954460 ↗MalfunctionSep 24, 2026Poor Quality Image
It was reported that the probe does not detect point. No patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883613 ↗MalfunctionSep 22, 2026Poor Quality Image; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861502 ↗MalfunctionSep 21, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848282 ↗MalfunctionSep 21, 2026Poor Quality Image
It was reported that the image quality is poor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843281 ↗MalfunctionSep 21, 2026Poor Quality Image
It was reported that the image quality is poor.No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842473 ↗MalfunctionSep 15, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778969 ↗MalfunctionSep 10, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714932 ↗MalfunctionSep 2, 2026Break; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566058 ↗MalfunctionAug 25, 2026Break; Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433149 ↗MalfunctionAug 19, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333391 ↗MalfunctionJul 29, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072946 ↗MalfunctionJun 9, 2026Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT THE PROBE IS CAUSING THE SR8 TO FREEZE UP WHEN IT IS PLUGGED IN. BIOMED TRIED THE PROBE ON SEVERAL DIFFERENT SR8'S AND ALL OF THEM FROZE WHEN THIS PROBE WAS PLUGGED IN. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446084 ↗MalfunctionJun 1, 2026Data Problem
IT WAS REPORTED THAT USER ADVISED THEY ARE NOT ABLE TO GET A CORRECT READING WHEN USING THE SENSOR FOR A PICC LINE. HAD THE USER TRY THE SENSOR ON ANOTHER ULTRASOUND, AND IT WORKED FINE. INACCURATE READINGS FOR MAGNETIC TIP. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350031 ↗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 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
- Navarre Opti-Drain8 models · 1,197 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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