CT Expres™ 3D 651207Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 47630039300096), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 death.

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. How this data works · Data updated Oct 13, 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 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE FEMALE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER BEING FOUND ON THE FLOOR AT HOME. THE PATIENT HAD BEEN ON THE FLOOR FOR THREE (3) DAYS BEFORE BEING TAKEN TO THE HOSPITAL, AND THAT THE PATIENT ARRIVED AT THE HOSPITAL WITH BRUISING ON HER LEFT SIDE. DURING A COMPUTED TOMOGRAPHY (CT) CHEST, ABDOMEN, AND PELVIS SCAN USING THE CT EXPRES 3D INJECTION SYSTEM, THE PATIENT APPEARED CONFUSED AND AGITATED AND THE PATIENT'S BLOOD PRESSURE WAS LESS THAN 90MMHG SYSTOLIC. THE CONSULTANT RADIOLOGIST TEAM REVIEWING THE PATIENT'S CASE OBSERVED AN AIR EMBOLUS. THE PATIENT DIED ON (B)(6) 2023.

  Patient problems: Air Embolism; Low Blood Pressure/ Hypotension

  MAUDE report 16643672 ↗