Sparq Diagnostic Ultrasound System 795090Recalls & reported problems
Philips Ultrasound LLC · Class 2
All models of SPARQ Diagnostic Ultrasound System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838097971), received between Apr 8, 2021 and Apr 8, 2021 — classified as 1 death.
The most frequently reported specific device problem is “No Visual Prompts/Feedback” (1 report).
1 FDA recall record name this device's identifier.
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
- Aug 19, 2021Class IITerminated
Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
Z-0070-2022 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- No Visual Prompts/Feedback1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 8, 2021No Visual Prompts/Feedback; No Visual Prompts/Feedback
A CUSTOMER REPORTED THEIR SPARQ ULTRASOUND SYSTEM FAILED WHILE IN THE EMERGENCY ROOM. THE TOUCH PANEL BECAME UNRESPONSIVE IMMEDIATELY AFTER TURNING THE SYSTEM ON TO PERFORM A DIAGNOSIS. THE DOCTOR WAS UNABLE TO DIAGNOSE THE PATIENT UNTIL ANOTHER ULTRASOUND SYSTEM ARRIVED. THIS DELAYED THE DOCTOR¿S DIAGNOSIS FOR 30 MINUTES AND THE PATIENT ULTIMATELY EXPIRED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 11638467 ↗
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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 · each recall links to the FDA recall notice
- 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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