LOGIQ E9 5205000-8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682124324), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (1 report).

1 other recall cover devices cleared under the same FDA submission (K142160); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Fire; Fire

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED DIFFICULTIES POWERING ON THE SYSTEM CONSOLE LOCATED IN THE INTERVENTIONAL RADIOLOGY (IR) DEPARTMENT. AFTER ATTEMPTING TO USE SEVERAL DIFFERENT OUTLETS, INCLUDING CHECKING THE BREAKER SWITCH, THE STAFF RECONNECTED THE SYSTEM AND POWERED IT ON. AT THAT POINT, A FLAME WAS OBSERVED ORIGINATING FROM THE SYSTEM. THE FLAME SELF-EXTINGUISHED IMMEDIATELY AFTER THE SYSTEM WAS UNPLUGGED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855472 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142160. One submission often covers many models, so check the product and lot details in each record.

• Z-2983-2018 · Mar 22, 2018 · Terminated
  GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast,