McKesson Horizon Medical Imaging Software Recalled for Archive Access Issues
McKesson Medical Imaging is recalling Horizon Medical Imaging software after a complaint that an unreported study could not be opened from the archive.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the issue involves a software defect preventing access to archived data without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
McKesson Medical Imaging is recalling 659 units of Horizon Medical Imaging software. This medical image and information management application is intended to receive, transmit, store, retrieve, display, print, and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
The recall was initiated after the firm received a complaint that an unreported study performed on a specific day could not be opened from the archive. The affected software versions include HMI 4.6.1, HMI 5.0 (Service Pack 1 through 8), HMI 11.0 (various sub-versions), HMI 11.5, HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, and McKesson Radiology 12.0.
The product was distributed worldwide, including all 50 US states, Puerto Rico, Australia, Canada, France, Great Britain, and Guam. Users of the affected software should contact McKesson Medical Imaging for further instructions on resolving the archive access issue.
The recalled product
- Product
- Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from va
- Manufacturer
- Mckesson Medical Immaging
- Affected units
- 659
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 (18)
- HMI 4.6.1
- HMI 5.0 (Service Pack 1: Service Pack 5
- Service Pack 7
- Service Pack 8)
- HMI 11.0 (11.0.3
- 11.0.4
- 11.0.5
- 11.0.6
- 11.0.6 FR EXP2
- 11.0.7
- 11.0.8)
- HMI 11.5 (11.5.1
- 11.5.2)
- HMI 11.6
- HMI 11.7
- HMI 11.8
- HIM 11.9
- McKesson Radiology 12.0
Distribution
Related recalls
Same manufacturer · Mckesson Medical Immaging
See all →- HighMcKesson Medical Imaging Software Recalled for Potential Image Display Errors
FDA (Devices) · 2016-03-23
- ModerateMcKesson Horizon Medical Imaging Software Recalled for Image Index Discrepancy
FDA (Devices) · 2014-08-06
- ModerateMcKesson Radiology-PACS software recall for missing high-priority alert icon
FDA (Devices) · 2014-05-21
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25