Merge RadSuite software recalled due to incorrect pixel value data
Merge Healthcare is recalling RadSuite software version V8.30.7.8 because incorrect pixel values may lead to patient injury or delayed diagnosis.
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 involves a medical device software defect that may result in patient injury or delayed diagnosis, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge RadSuite software, version V8.30.7.8. The recall is due to a defect where the values provided from the Pixel Value tool do not appear to be correct.
The potentially affected software was distributed to medical facilities in Alabama, Indiana, Michigan, Pennsylvania, and Wisconsin. A total of 8 sites have the potentially affected version.
The incorrect data may result in potential patient injury or delay in diagnosis or treatment. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 8
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)
- Version V8.30.7.8
Distribution
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 · incorrect data
See all →- HighMerge Healthcare Recalls Merge LIS Software Due to Medication Display Error
FDA (Devices) · 2020-11-04
- HighSICAT IMPLANT V2.0 Software Recall Due to Incorrect Implant Position Export
FDA (Devices) · 2020-09-16
- HighAbaxis Recalls Piccolo Xpress Chemistry Analyzers Due to Incorrect Reference Ranges
FDA (Devices) · 2020-06-24
- HighRayStation 8B Software Recalled for Pitch and Roll Correction Errors
FDA (Devices) · 2020-03-18
- HighRayStation 8B Software Recalled for Pitch and Roll Correction Errors
FDA (Devices) · 2020-03-18
Similar recalls
- ModerateMerge Healthcare Recalls RadSuite Software Due to Image Display Errors
FDA (Devices) · 2016-09-07
- HighMerge Healthcare Recalls RadSuite Software Due to Missing Studies
FDA (Devices) · 2016-09-21
- HighMerge Healthcare Recalls RadSuite Software Due to Image Display Error
FDA (Devices) · 2016-08-31
- HighMerge RadSuite software recalled due to patient demographic misapplication risk
FDA (Devices) · 2016-09-14
- ModerateMerge Healthcare Recalls RadSuite Picture Archive System for Measurement Errors
FDA (Devices) · 2016-02-17
- SevereMerge OrthoCase software recall due to measurement errors
FDA (Devices) · 2016-12-28