Merge Healthcare CADstream software recall for missing PURE filter message
Merge Healthcare is recalling CADstream software versions prior to 5.2.9 because the PURE filter user interface message may not display, potentially leading to incorrect patient follow-up.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of incorrect patient follow-up, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling CADstream software versions prior to 5.2.9. The recall is due to a software defect where the PURE filter user interface message does not display on DICOM transfer studies. This issue occurs when a site begins using the PURE filter.
The failure to display the user interface message may result in incorrect patient follow-up. The affected software was distributed worldwide, including nationwide in the USA, as well as to foreign, military, and government entities. Approximately 844 sites potentially have the affected versions.
Healthcare facilities should contact Merge Healthcare for information on how to resolve the software issue. Consumers are not directly affected by this recall, as the product is medical software used by healthcare providers.
The recalled product
- Product
- CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 844
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Versions prior to 5.2.9
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Merge Healthcare, Inc.
See all →- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- HighMerge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
FDA (Devices) · 2026-08-12
- SevereMerge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
FDA (Devices) · 2026-08-12
- ModerateHemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
- HighVERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue
FDA (Devices) · 2025-03-26
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighMerge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up
FDA (Devices) · 2016-10-26
- HighMerge Healthcare Recalls CADstream MRI Software Due to Grid Selection Error
FDA (Devices) · 2016-09-28
- ModerateMerge Healthcare Recalls iConnect Access Software Due to Display Error
FDA (Devices) · 2016-11-23
- HighMerge Healthcare Recalls RadSuite Software Due to Missing Studies
FDA (Devices) · 2016-09-21
- HighMerge Cardio software recall due to incorrect patient data saving
FDA (Devices) · 2016-09-07
- HighMerge PACS Software Recalled for Potential Image Display Defect
FDA (Devices) · 2017-06-21