EPIQ 5 Diagnostic Ultrasound System 795120Recalls & 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
- 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 00884838097858), received between Jan 13, 2022 and Jan 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect Measurement” (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.
Most reported problems
Device problems
- Incorrect Measurement1
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.
MalfunctionJan 13, 2022Incorrect Measurement; Incorrect Measurement
A CUSTOMER REPORTED THEIR EPIQ 5 DIAMOND SELECT ULTRASOUND SYSTEM WAS PRODUCING INCORRECT FETAL CALCULATIONS FOR AVERAGE PULSATILITY INDEX (PI) FOR UMBILICAL ARTERY, MEDIUM CEREBRAL ARTERY (MCA), AND DUCTUS VENOSUS. THERE WAS NO ALLEGATION OF ALTERED PATIENT OUTCOME AS A RESULT OF THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13253381 ↗
Other System, imaging, pulsed doppler, ultrasonic devices
- Transducer C5-1 989605412042Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic11 recalls0 reports
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- EPIQ 7 Diagnostic Ultrasound System 989605386721Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls2 deaths146 reports
- Transducer S7-3t 989605406772Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic5 recalls1 death18 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed doppler, ultrasonic199 reports
- Transducer S7-3t 989605439232Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls4 reports
- Transducer 3D9-3v 989605395622Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls1 report
- ACUSON Redwood Diagnostic Ultrasound System 11503314Siemens Medical Solutions USA, Inc. · System, imaging, pulsed doppler, ultrasonic3 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.
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