Affiniti CVx Diagnostic Ultrasound System 795190 (UDI 00884838114166)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838114166), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 death.

The most frequently reported specific device problem is “Poor Quality Image” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathMar 5, 2026Poor Quality Image

  A PHILIPS ULTRASOUND SYSTEM AND MODEL X7-2T TRANSDUCER WAS ASSOCIATED WITH A PATIENT DEATH EVENT. THE PATIENT UNDERWENT A CARDIAC PROCEDURE (IMPLANTATION OF AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD)) FOR TREATMENT OF VENTRICULAR TACHYCARDIA. ADDITIONAL FOLLOW-UP CARE WAS NEEDED 16 DAYS LATER, AND A DEVICE-RELATED PROBLEM (DETERIORATION IN IMAGE QUALITY) WAS REPORTED DURING THIS INCIDENT. ACCORDING TO THE CUSTOMER, THE IMAGE QUALITY DID NOT APPEAR TO HAVE HAD ANY CONSEQUENCE ON THE SUBSEQUENT COURSE OF CARE. THE PATIENT'S CONDITION DETERIORATED TO MULTI-ORGAN FAILURE AND THE PATIENT ULTIMATELY DIED A FEW DAYS LATER OF CARDIOGENIC SHOCK IN THE CONTEXT OF END-STAGE HEART FAILURE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Cardiogenic Shock; Cardiomyopathy; Heart Failure/Congestive Heart Failure; Septic Shock; Thromboembolism

  MAUDE report 24526939 ↗