EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM 795205Recalls & reported problems
Philips Ultrasound LLC · Class 2
All models of EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838097902), received between Jan 14, 2021 and Jan 3, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Unintended System Motion” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended System Motion3
- Application Program Freezes or Fails to Launch1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED DURING AN UNKNOWN CRITICAL PROCEDURE, THE EPIQ 5 ULTRASOUND REPEATEDLY FROZE AND COULD NOT BE OPERATED. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER THE SYSTEM WAS EXCHANGED. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072488 ↗MalfunctionJan 24, 2023Unintended System Motion; Unintended System Motion
A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 5C ULTRASOUND SYSTEM'S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16233249 ↗MalfunctionDec 19, 2022Unintended System Motion; Unintended System Motion
A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ 5 ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16004938 ↗MalfunctionJan 14, 2021Unintended System Motion; Unintended System Motion
THE CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR EPIQ ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY AND DURING CLINICAL USE. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11171269 ↗
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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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