SPARQ Diagnostic Ultrasound System 989605394911Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884838028098), received between May 6, 2021 and Jan 8, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

1. 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

Recent adverse event reports

The 7 most recent of 7 reports, 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 ↗