CLEARVUE 850 DIAGNOSTIC ULTRASOUND SYSTEM 795226Recalls & reported problems
Philips Ultrasound LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838097711), received between Sep 4, 2024 and Jan 2, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Unintended Electrical Shock” (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
- Adverse Event Without Identified Device or Use Problem1
- Unintended Electrical Shock1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- Numbness1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLEARVUE 850 ULTRASOUND SYSTEM WAS ASSOCIATED WITH A PATIENT SERIOUS INJURY EVENT. IT WAS REPORTED THE TRANSDUCER MALFUNCTIONED DURING NORMAL USE WITH THEIR CLEARVUE 850 ULTRASOUND SYSTEM. THE CUSTOMER ALLEGED THE MALFUNCTION CAUSE SERIOUS INJURY TO THE PATIENT. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. AT THIS TIME THERE IS INSUFFICIENT INFORMATION WITHIN THE EVENT DESCRIPTION TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 21063193 ↗InjurySep 4, 2024Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THE USER FELT OCCASIONAL ELECTRICAL LEAKAGE FROM THE C5-2 TRANSDUCER. THE USER REPORTED SENSING A LEAK AND HAVING NUMBNESS, BUT NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER REPORTED THE TRANSDUCER PASSES THE LEAKAGE TEST. THE CUSTOMER¿S IMMEDIATE CONCERNS WERE ADDRESSED BY REPLACING THE TRANSDUCER. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: Numbness
MAUDE report 20137321 ↗
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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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