Site~Rite Halcyon Diagnostic Ultrasound SystemRecalls & reported problems
CHISON Medical Technologies Co., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06945121412018), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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.
Reports received per month
Most reported problems
Device problems
- Application Program Freezes or Fails to Launch1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT DURING A PICC PLACEMENT, THE UNIT FROZE WHEN SWITCHED TO THE SITE RITE MODE (ULTRASOUND FUNCTION WORKED NORMALLY). THE UNIT WOULD NOT RESET OR RELOAD, SO IT WAS POWERED OFF. AFTER SHUTDOWN, IT FAILED TO POWER BACK ON UNTIL THE FOLLOWING MORNING. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23608563 ↗
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 18, 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