Site-Rite 9770500RRecalls & reported problems
Bard Access Systems, Inc. · SITE-RITE 8 ULTRASOUND SYSTEM, US Refurbished · Class 2
All models of Site-Rite (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741104121), received between Jul 3, 2018 and Jan 23, 2026 — classified as 9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image4
- Application Program Freezes or Fails to Launch1
- Battery Problem1
- Break1
- Failure to Charge1
- Failure to Power Up1
- Image Display Error/Artifact1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Product Quality Problem
FOUND DURING EVALUATION: THERE ARE CRACKS IN THE TRANSDUCER HOUSINGS AT THE END AND ON THE EDGES OF THE TRANSDUCER WINDOW. THE PROBE IMAGE IS NOT CLEAR AT THE TOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24162119 ↗MalfunctionAug 27, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE ARE IMAGING ISSUES. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903015 ↗MalfunctionApr 17, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CUSTOMER SEES IMAGE BUT CAN NO LONGER CAN DETECT TIP OF NEEDLE. CONSISTENTLY BEEN HAPPENING AS OF LAST WEEK. VERIFIED SHE HAS GONE THROUGH MULTIPLE KITS. THE EXACT NUMBER WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16753035 ↗MalfunctionNov 4, 2022Break; Break
RUBBER PEELED OFF THE PROBE STRAIN RELIEF AND WIRES ARE EXPOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15738806 ↗MalfunctionApr 23, 2021Poor Quality Image; Poor Quality Image
PER OFFICE MANAGER, HAVING IMAGE ISSUES, THEY SAY IT'S TOO BRIGHT AND GRAINY NO MATTER WHAT IS DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11717119 ↗MalfunctionDec 28, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
MalfunctionFeb 28, 2019Failure to Power Up; Battery Problem; Unexpected Shutdown; Battery Problem
PER PICC NURSE: THE UNIT WAS PLUGGED IN AND HAD 78% POWER BUT JUST SHUTDOWN AND WOULD NOT REBOOT FOR MORE THAN 5 MINUTES.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8380507 ↗MalfunctionJan 2, 2019Failure to Charge
IT WAS REPORTED THAT THE UNIT BATTERY DOES NOT HOLD A CHARGE. BIOMED REPORTED WHEN THE SYSTEM IS PLUGGED IN, THE SYSTEM SHOWS THE BATTERY IS CHARGING, HOWEVER, AFTER CHARGING FOR SOME TIME, THE SYSTEM ONLY RUNS FOR A FEW MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8210826 ↗MalfunctionJul 3, 2018Image Display Error/Artifact; Poor Quality Image
SALES REP REPORTED SYSTEM DISPLAYS A HAZY, POOR IMAGE QUALITY THAT IS EXTREMELY BLURRY AND "CONVOLUTED".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7661074 ↗
Other System, imaging, pulsed echo, ultrasonic devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
- Site~Rite 8 Ultrasound System 9770600Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic629 reports
- Site-Rite 9770501Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic546 reports
- Transducer X8-2t 989605455171Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic8 recalls19 reports
- Transducer C10-3v 989605409562Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic7 recalls0 reports
- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 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 16, 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