CADstream 6.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00842000101116), received between Jan 18, 2025 and Jan 18, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE-MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187617 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187616 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187615 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187613 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187612 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187611 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187610 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, (B)(6) HEALTHCARE RECEIVED A COMPLAINT FROM A (B)(6) CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. (B)(6)HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. (B)(6) TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, (B)(6) HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187609 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON 12/06/2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S DIAGNOSTIC ASSESSMENT CATEGORY WAS REVISED. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON THE REVISED DIAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187608 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON (B)(6)2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE-MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE RE-PROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. THERE HAS BEEN NO REPORT OF PATIENT HARM.

  Patient problems: Breast Mass; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21187607 ↗
• InjuryJan 18, 2025Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  ON (B)(6)2024, MERGE HEALTHCARE RECEIVED A COMPLAINT FROM A MERGE CADSTREAM CUSTOMER ALLEGING THAT THE SYSTEM DID NOT HIGHLIGHT IMAGES FROM A PATIENT WITH MALIGNANCY. MERGE HEALTHCARE TECHNICAL SUPPORT CONNECTED TO THE CUSTOMER'S SYSTEM TO TROUBLESHOOT THE ISSUE. TECHNICAL SUPPORT FOUND THAT THE CUSTOMER'S DEFAULT STUDY PREFERENCE (DSP) HAD NOT BEEN OPTIMIZED FOR IMAGE ANALYSIS WITH A PRE-MASK SEQUENCE AND THE DYNAMIC SEQUENCE WITH PEAK CONTRAST. MERGE TECHNICAL SUPPORT WORKED WITH THE CUSTOMER AND ADJUSTED THE DSP CONFIGURATION SETTINGS TO ENHANCE IMAGE ANALYSIS. THE PATIENT'S STUDY WAS RE-PROCESSED BY CADSTREAM WITH THE OPTIMIZED DSP CONFIGURATION. THE CUSTOMER REVIEWED THE REPROCESSED STUDY AND CONFIRMED THAT THE HIGHLIGHTING IS WORKING AS EXPECTED. ON 12/19/2024, MERGE HEALTHCARE RECEIVED ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATING THAT THEY HAD RE-PROCESSED AND REVIEWED IMAGES FOR PATIENTS WHOSE IMAGES HAD BEEN REVIEWED BASED ON THE PRIOR DSP CONFIGURATION. AFTER A RADIOLOGIST RE-REVIEWED A PATIENT'S IMAGES WITH THE OPTIMIZED DSP CONFIGURATION, THE PATIENT'S TREATMENT PLAN WAS REVISED TO INCLUDE ADDITIONAL TESTING. THERE HAS BEEN NO REPORT OF PATIENT HARM BECAUSE ON TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass

  MAUDE report 21187606 ↗

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