Lumify Diagnostic Ultrasound System 989605449841Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838064713), received between Oct 8, 2024 and Oct 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Device Output” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 31, 2025Class IIOpen, Classified

   Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

   Z-0883-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024No Device Output; No Device Output

  A CUSTOMER REPORTED THEIR LUMIFY ULTRASOUND SYSTEM FAILED TO COMPLETE THE BOOT UP PROCESS DURING A TRAUMA HELICOPTER FLIGHT DUE TO IMPROPER USE OF THE DEVICE. THE CUSTOMER HAD TO RESTART THE LUMIFY DEVICE MORE THAN 5 TIMES. THE DELAY CAUSED BY THE MULTIPLE RESTARTS IS ALLEGED TO HAVE RESULTED IN DELAY AND SUBOPTIMAL CARE DUE TO THE ULTRASOUND BEING UNAVAILABLE. IT IS UNCLEAR WHETHER THE LUMIFY SYSTEM WAS USED TO PROVIDE ULTRASOUND IMAGES. THE PATIENT WAS IN CRITICAL TRAUMA CONDITION WHICH IS A LIFE-THREATENING SITUATION BUT ULTIMATELY SURVIVED. THE PATIENT REQUIRED MEDICAL INTERVENTION, BUT THE INTERVENTION TYPE WAS NOT PROVIDED.

  Patient problems: Mydriasis

  MAUDE report 20428606 ↗
• MalfunctionOct 8, 2024No Device Output; No Device Output

  A CUSTOMER REPORTED THEIR LUMIFY ULTRASOUND SYSTEM FAILED TO COMPLETE THE BOOT UP PROCESS DURING A TRAUMA HELICOPTER FLIGHT DUE TO IMPROPER USE OF THE DEVICE. THE CUSTOMER HAD TO RESTART THE LUMIFY DEVICE MORE THAN 5 TIMES. THE DELAY CAUSED BY THE MULTIPLE RESTARTS IS ALLEGED TO HAVE RESULTED IN DELAY AND SUBOPTIMAL CARE DUE TO THE ULTRASOUND BEING UNAVAILABLE. IT IS UNCLEAR WHETHER THE LUMIFY SYSTEM WAS USED TO PROVIDE ULTRASOUND IMAGES. THE PATIENT WAS IN CRITICAL TRAUMA CONDITION WHICH IS A LIFE-THREATENING SITUATION BUT ULTIMATELY SURVIVED. THE PATIENT REQUIRED MEDICAL INTERVENTION, BUT THE INTERVENTION TYPE WAS NOT PROVIDED.

  Patient problems: Mydriasis

  MAUDE report 20395423 ↗