EPIQ 5 Ultrasound System 795204Recalls & reported problems
Philips Ultrasound LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838107502), received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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
- Human-Device Interface Problem1
Patient problems
- Electric Shock1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Human-Device Interface Problem
It was reported the user felt the sensations as tingling and shooting pain in the arm lasting approximately 5-10 seconds when using the L12-5 transducer. The L12-5 transducer was associated with an EPIQ 5G Ultrasound System. The user was evaluated and received unspecified medical treatment. The customer confirmed that the symptoms are a direct result of the use of the transducer. The treatment and associated diagnosis were unspecified. Philips has started an investigation, and upon completion, a follow-up report will be submitted.
Patient problems: Electric Shock; Insufficient Information; Pain
MAUDE report 50900342 ↗
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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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