SPARQ Diagnostic Ultrasound SystemRecalls & reported problems across all models
Philips Ultrasound LLC · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of SPARQ Diagnostic Ultrasound System by Philips Ultrasound LLC in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2021 and Jan 8, 2026 — classified as 1 death, 7 malfunctions.
The most frequently reported specific device problem is “No Visual Prompts/Feedback” (2 reports).
1 FDA recall record name at least one of these models by its device 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. 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
SPARQ 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.
- 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 · names 2 of these models · Recall details · FDA record ↗
Most reported SPARQ Diagnostic Ultrasound System problems
Device problems
- No Visual Prompts/Feedback2
- Detachment of Device or Device Component1
- Image Display Error/Artifact1
- Mechanical Jam1
- Patient Data Problem1
- Unexpected Shutdown1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Hemorrhage/Blood Loss/Bleeding1
SPARQ Diagnostic Ultrasound System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPARQ Diagnostic Ultrasound System 989605394911System, imaging, pulsed echo, ultrasonic1 recall7 reports
- Sparq Diagnostic Ultrasound System 795090Transducer, ultrasonic, diagnostic1 recall1 death1 report
Recent SPARQ Diagnostic Ultrasound System adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026Detachment of Device or Device Component
A CUSTOMER REPORTED THERE WAS DETACHMENT OF THE SPARQ ULTRASOUND SYSTEM DISPLAY ARTICULATION ARM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THIS ISSUE WAS DISCOVERED OUTSIDE CLINICAL USE. THE PHILIPS FIELD SERVICE ENGINEER REPLACED THE DISPLAY ARTICULATION ARM TO RESOLVE THE CUSTOMER¿S IMMEDIATE CONCERNS. 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 24001443 ↗MalfunctionOct 15, 2025Unexpected Shutdown; Unexpected Shutdown
A CUSTOMER REPORTED THEIR SPARQ ULTRASOUND SYSTEM SHUT DOWN WHILE PERFORMING A NERVE BLOCK FOR A PATIENT. AFTER REBOOTING, THE SYSTEM DISPLAYED AN ERROR MESSAGE AND COULD NOT BE STARTED, WHICH DELAYED THE PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 23292736 ↗MalfunctionNov 5, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED BY THE CUSTOMER THAT THE X7-2T TEE TRANSDUCER WOULD NOT ARTICULATE DURING USE WITH AN EPIQ 7C ULTRASOUND SYSTEM. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. IT IS UNKNOWN IF THE EXAM WAS COMPLETED. A QUOTE FOR A REPLACEMENT WAS PROVIDED. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609572 ↗MalfunctionOct 4, 2024Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THE CUSTOMER USER RECEIVED A SHOCK WHEN PLUGGING THE SPARQ ULTRASOUND SYSTEM INTO AN ELECTRICAL OUTLET. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME AND THE USER REPORTED THEY RECEIVED NO INJURY. IT WAS REPORTED THE POWER CABLE WAS FRAYED AND HAD EXPOSED WIRES. THE PHILIPS SERVICE ENGINEER EVALUATED THE SYSTEM AND CONFIRMED THE POWER CABLE WAS DAMAGED. THE CUSTOMER¿S IMMEDIATE CONCERNS WERE ADDRESS BY REPLACING THE POWER CABLE. A FAILURE ANALYSIS OF THE SUSPECTED PART WAS NOT ABLE TO BE PERFORMED AS IT WAS NOT RETURNED. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20372393 ↗MalfunctionApr 13, 2022Image Display Error/Artifact; Image Display Error/Artifact
A CUSTOMER REPORTED THEIR SPARQ ULTRASOUND SYSTEM LOCKED UP AND DISPLAYED VERTICAL LINE ARTIFACTS DURING TRANSESOPHAGEAL TRANSDUCER USE FOR EXPLORATORY SURGERY. THE PROCEDURE WAS ABLE TO CONTINUE WITHOUT THE SPARQ SYSTEM USING THE IMAGES PREVIOUSLY ACQUIRED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14103428 ↗MalfunctionJan 19, 2022Patient Data Problem; Patient Data Problem
A CUSTOMER REPORTED PATIENT IMAGES WERE CORRUPTED AND MIXED WITH DIFFERENT STUDIES AFTER EXPORTING FROM THEIR SPARQ ULTRASOUND SYSTEM TO A USB DRIVE. THE IMAGES WERE CORRECT ON THE SYSTEM AND THE DIAGNOSIS WAS PERFORMED SUCCESSFULLY. THE ISSUE WAS OBVIOUS TO THE USER AND THERE WAS NO HARM TO THE USER OR PATIENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13293654 ↗MalfunctionMay 6, 2021No Visual Prompts/Feedback; No Visual Prompts/Feedback
A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WITH THEIR SPARQ ULTRASOUND SYSTEM DURING A SURGICAL PROCEDURE. WHILE PERFORMING A LIVE TRANSABDOMINAL IMAGE SCAN FOR A DILATION AND CURETTAGE (D&C) WITH HYSTEROSCOPY PROCEDURE, THE SYSTEM LOCKED UP AND COULD NOT BE RESTARTED. THE PATIENT NEEDED TO BE SENT BY AMBULANCE TO ANOTHER FACILITY TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE OUTCOME TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11785588 ↗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 ↗
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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