Affiniti CVx Diagnostic Ultrasound System 795190 (UDI 00884838106598)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838106598), received between Feb 4, 2022 and Jul 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A CUSTOMER REPORTED AN AFFINITI ULTRASOUND SYSTEM MONITOR DETACHED FROM THE ARTICULATING ARM SUPPORT. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE FIELD SERVICE ENGINEER REPLACED THE ARTICULATING MONITOR ARM TO RESOLVE THE ISSUE. 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 19771075 ↗
• MalfunctionJul 24, 2023Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THAT THE CONTROL PANEL ARM WAS SWIVELING DURING TRANSPORT OF AN AFFINITI CVX ULTRASOUND SYSTEM. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF DISCOVERY. NO PATIENT OR USER WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379711 ↗
• MalfunctionMay 26, 2023Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THE CONTROL PANEL COULD NOT BE LOCKED IN PLACE ON THEIR AFFINITI ULTRASOUND SYSTEM WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011730 ↗
• MalfunctionDec 29, 2022Unexpected Shutdown; Unexpected Shutdown

  A CUSTOMER REPORTED THAT AN AFFINITI CVX ULTRASOUND SYSTEM WAS SHUTTING DOWN ON ITS OWN. IT IS UNKNOWN IF THIS OCCURRED DURING A CRITICAL PROCEDURE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073829 ↗
• MalfunctionFeb 4, 2022Unintended System Motion; Unintended System Motion

  A CUSTOMER REPORTED THE SWIVEL MECHANISM OF THEIR AFFINITI CVX ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. A PHILIPS SERVICE ENGINEER ADJUSTED AND SECURED THE TRIGGER CABLE TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE ULTRASOUND SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13456054 ↗