CADstream 6.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842000100638), received between Mar 9, 2021 and Aug 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K092954); they may or may not involve this specific model.

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.

• MalfunctionAug 3, 2021Use of Device Problem; Use of Device Problem

  CADSTREAM IS INTENDED TO BE USED IN THE VISUALIZATION, ANALYSIS, AND REPORTING OF MAGNETIC RESONANCE IMAGING (MRI) STUDIES. CADSTREAM SUPPORTS EVALUATION OF DYNAMIC MR DATA ACQUIRED DURING CONTRAST ADMINISTRATION. CADSTREAM PERFORMS OTHER USER SELECTED PROCESSING FUNCTIONS (SUCH AS IMAGE REGISTRATION, SUBTRACTIONS, MEASUREMENTS, 3D RENDERINGS, AND REFORMATS). ON 7/12/2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REQUEST ASSISTANCE WITH RE-PRCESSING IMAGES THAT WERE BELIEVED TO BE PROCESSED INCORRECTLY. SUPPORT REVIEWED THE INCOMING IMAGES AND SYSTEM REMOTELY. SUPPORT FOUND THAT THE IMAGES APPEARED TO BE SCANNED WITH INCORRECT PATIENT ORIENTATION. THE CUSTOMER CONFIRMED THE ORIENTATION OF THE IMAGES. CADSTREAM DOES NOT ALLOW FOR THE EDITING OR MODIFICATION OF THE ORIGINAL IMAGE. THE CUSTOMER HAS THE ABILITY TO MAKE ANNOTATIONS REGARDING THE ORIENTATION, HOWEVER, CADSTREAM WILL CONTINUE TO REFLECT THE ORIENTATION AS ORIGINALLY SCANNED ON THE PROCESSED IMAGES. SUPPORT INSTRUCTED THE CUSTOMER REGARDING THESE IMAGES AND ORIENTATION. THE INCORRECT ORIENTATION IS NOT A MALFUNCTION OF THE CADSTREAM DEVICE NOR IS IT A FAILURE OF THE DEVICE TO MEET SPECIFICATION. THE ISSUE IS USE ERROR CAUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271516 ↗
• MalfunctionMar 9, 2021Use of Device Problem; Use of Device Problem

  CADSTREAM IS INTENDED TO BE USED IN THE VISUALIZATION, ANALYSIS, AND REPORTING OF MAGNETIC RESONANCE IMAGING (MRI) STUDIES. CADSTREAM SUPPORTS EVALUATION OF DYNAMIC MR DATA ACQUIRED DURING CONTRAST ADMINISTRATION. CADSTREAM PERFORMS OTHER USER SELECTED PROCESSING FUNCTIONS (SUCH AS IMAGE REGISTRATION, SUBTRACTIONS, MEASUREMENTS, 3D RENDERINGS, AND REFORMATS). ON (B)(6) 2021, A CUSTOMER CONTACTED MERGE HEALTHCARE TO REQUEST ASSISTANCE WITH RE-PROCESSING IMAGES THAT WERE BELIEVED TO BE PROCESSED INCORRECTLY. SUPPORT REVIEWED THE INCOMING IMAGES AND SYSTEM REMOTELY. SUPPORT FOUND THAT THE IMAGES APPEARED TO BE SCANNED WITH INCORRECT PATIENT ORIENTATION. THE CUSTOMER CONFIRMED THE ORIENTATION OF THE IMAGES. CADSTREAM DOES NOT ALLOW FOR THE EDITING OR MODIFICATION OF THE ORIGINAL IMAGE. THE CUSTOMER HAS THE ABILITY TO MAKE ANNOTATIONS REGARDING THE ORIENTATION, HOWEVER, CADSTREAM WILL CONTINUE TO REFLECT THE ORIENTATION AS ORIGINALLY SCANNED ON THE PROCESSED IMAGES. SUPPORT INSTRUCTED THE CUSTOMER REGARDING THESE IMAGES AND ORIENTATION.. THE INCORRECT ORIENTATION IS NOT A MALFUNCTION OF THE CADSTREAM DEVICE NOR IS IT A FAILURE OF THE DEVICE TO MEET SPECIFICATION. THE ISSUE IS USE ERROR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448468 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092954. One submission often covers many models, so check the product and lot details in each record.

• Z-0137-2017 · Jan 30, 2016 · Terminated
  CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
• Z-2871-2016 · Nov 1, 2012 · Terminated
  CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) st
• Z-0118-2017 · Oct 19, 2011 · Terminated
  CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) st