Lumify Diagnostic Ultrasound System 795005 (UDI 00884838100121)Recalls & reported problems
Philips Ultrasound LLC · Class 2
All models of Lumify Diagnostic Ultrasound System (3)
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 00884838100121), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K203406); 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. 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
- Application Program Freezes or Fails to Launch1
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.
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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K203406. One submission often covers many models, so check the product and lot details in each record.
- Z-0883-2026 · Oct 31, 2025 · Open, ClassifiedLumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
- Z-2374-2025 · Jul 3, 2025 · Open, ClassifiedL12-4 Lumify Transducer Probe
- Z-2392-2025 · Jul 3, 2025 · Open, ClassifiedS4-1 Lumify Transducer Probe
Other System, Imaging, Pulsed Echo, Ultrasonic devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
- Site~Rite 8 Ultrasound System 9770600Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic629 reports
- Site-Rite 9770501Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic546 reports
- Transducer X8-2t 989605455171Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic8 recalls19 reports
- Transducer C10-3v 989605409562Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic7 recalls0 reports
- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 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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