IMPAX 6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05400874000727), received between Mar 31, 2025 and Mar 31, 2025 — classified as 2 deaths.

The most frequently reported specific device problem is “Installation-Related Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 31, 2025Installation-Related Problem; Insufficient Device Problem Information; Installation-Related Problem; Insufficient Device Problem Information

  ON (B)(6) 2025, A CUSTOMER REPORTED THE FOLLOWING INCIDENT TO AGFA HEALTHCARE THROUGH COMPLAINT (B)(4): A 40-YEAR-OLD FEMALE PATIENT ARRIVED IN THE EMERGENCY IN CARDIAC AND RESPIRATORY ARREST. WHEN THE RADIOLOGIST, READING FROM A REMOTE HOME STATION, ATTEMPTED TO VIEW THE IMAGES, AN ERROR MESSAGE 'PROBLEM DOWNLOADING IMAGE, WILL ATTEMPT TO RETRY" DISPLAYED AND COULD NOT VIEW THE CT AND CTA IMAGES. THE RADIOLOGIST USER RESTARTED THE WORKSTATION WHICH TOOK APPROXIMATELY 4-5 MINUTES AFTER WHICH THE IMAGES COULD BE SUCCESSFULLY VIEWED. THE CUSTOMER REPORTED THAT THE INABILITY TO VIEW THE IMAGES DURING THE EMERGENCY SITUATION CAUSED THEM TO LOSE VALUABLE MINUTES IN MAKING THE DIAGNOSIS. THE VIEWING ISSUE HAPPENED AROUND 8 AM AND THE PATIENT PASSED AWAY AT 10:25 PM LATER THAT DAY. SUMMARY: TAKING ALL FACTORS INTO CONSIDERATION, INCLUDING PATIENT HISTORY, CLINICAL PRESENTATION UPON ED ARRIVAL WITH FIXED PUPILS, DIAGNOSTIC IMAGING FINDINGS, MEDICAL MANAGEMENT PRE AND POST DIAGNOSTIC IMAGING ACQUISITION, AND CAUSE OF DEATH; BASED ON CLINICAL EXPERIENCE, AGFA HEALTHCARE BELIEVES THAT THE 5 MINUTE DELAY IN IMAGE VIEWING BY THE READING RADIOLOGIST DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S D

  Patient problems: Cardiac Arrest; Pneumonia

  MAUDE report 21731205 ↗
• DeathMar 31, 2025Installation-Related Problem; Insufficient Device Problem Information; Installation-Related Problem; Insufficient Device Problem Information

  ON MARCH 12, 2025, A CUSTOMER REPORTED THE FOLLOWING INCIDENT TO AGFA HEALTHCARE THROUGH COMPLAINT (B)(4): A 40-YEAR-OLD FEMALE PATIENT ARRIVED IN THE EMERGENCY IN CARDIAC AND RESPIRATORY ARREST. WHEN THE RADIOLOGIST, READING FROM A REMOTE HOME STATION, ATTEMPTED TO VIEW THE IMAGES, AN ERROR MESSAGE 'PROBLEM DOWNLOADING IMAGE, WILL ATTEMPT TO RETRY" DISPLAYED AND COULD NOT VIEW THE CT AND CTA IMAGES. THE RADIOLOGIST USER RESTARTED THE WORKSTATION WHICH TOOK APPROXIMATELY 4-5 MINUTES AFTER WHICH THE IMAGES COULD BE SUCCESSFULLY VIEWED. THE CUSTOMER REPORTED THAT THE INABILITY TO VIEW THE IMAGES DURING THE EMERGENCY SITUATION CAUSED THEM TO LOSE VALUABLE MINUTES IN MAKING THE DIAGNOSIS. THE VIEWING ISSUE HAPPENED AROUND 8 AM AND THE PATIENT PASSED AWAY AT 10:25 PM LATER THAT DAY. SUMMARY: TAKING ALL FACTORS INTO CONSIDERATION, INCLUDING PATIENT HISTORY, CLINICAL PRESENTATION UPON ED ARRIVAL WITH FIXED PUPILS, DIAGNOSTIC IMAGING FINDINGS, MEDICAL MANAGEMENT PRE AND POST DIAGNOSTIC IMAGING ACQUISITION, AND CAUSE OF DEATH; BASED ON CLINICAL EXPERIENCE, AGFA HEALTHCARE BELIEVES THAT THE 5 MINUTE DELAY IN IMAGE VIEWING BY THE READING RADIOLOGIST DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'

  Patient problems: Cardiac Arrest; Pneumonia

  MAUDE report 21731179 ↗