Lumify Diagnostic Ultrasound SystemRecalls & reported problems across all models
Philips Ultrasound LLC · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Lumify Diagnostic Ultrasound System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Lumify Diagnostic Ultrasound System by Philips Ultrasound LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2024 and Aug 27, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “No Device Output” (2 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Lumify Diagnostic Ultrasound System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Lumify Diagnostic Ultrasound System problems
Device problems
- No Device Output2
- Application Program Freezes or Fails to Launch1
Patient problems
- Mydriasis2
- No Clinical Signs, Symptoms or Conditions1
Lumify Diagnostic Ultrasound System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lumify Diagnostic Ultrasound System 989605449841System, imaging, pulsed doppler, ultrasonic1 recall2 reports
- Lumify Diagnostic Ultrasound System 795005System, Imaging, Pulsed Echo, Ultrasonic1 recall0 reports
- Lumify Diagnostic Ultrasound System 795005System, Imaging, Pulsed Echo, Ultrasonic1 report
Recent Lumify Diagnostic Ultrasound System adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THEIR LUMIFY ULTRASOUND SYSTEM DISPLAYED AN ERROR DURING AN UNSPECIFIED EMERGENCY PROCEDURE. THE SYSTEM DISPLAYED LICENSE EXPIRED AND WAS NOT ABLE TO BE USED. ANOTHER ULTRASOUND SYSTEM WAS USED FOR THE PROCEDURE. THERE WAS NO USER OR PATIENT HARM AS A RESULT OF THE ISSUE. THE SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM AND RESOLVED THE ISSUE BY RE-REGISTERING THE PROBE IN A STABLE NETWORK. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902291 ↗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 ↗
Other Philips Ultrasound LLC products
- Transducer C5-13 models · 0 reports · 12 recalls
- EPIQ Diagnostic Ultrasound System9 models · 281 reports · 5 recalls
- Transducer X5-13 models · 0 reports · 10 recalls
- EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM5 models · 330 reports · 3 recalls
- Transducer C10-3v2 models · 0 reports · 7 recalls
- Transducer X7-2t4 models · 26 reports · 6 recalls
- Transducer C5-210 models · 0 reports · 6 recalls
- Transducer S5-12 models · 0 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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