McKesson Horizon Medical Imaging Software Recalled for Image Index Discrepancy
McKesson Medical Imaging is recalling Horizon Medical Imaging software due to a defect that may cause a mismatch between the expected image index and the actual folder content.
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 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software discrepancy that may affect data integrity, fitting the criteria for a moderate severity recall without reported adverse health consequences.
Plain-English summary
McKesson Medical Imaging is recalling 659 units of Horizon Medical Imaging software. The product is a medical image and information management application 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 because the firm identified a software issue that may cause a discrepancy between the index of images expected by the application and the actual content of the folder storing the images. The affected software versions include HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, and MR 12.0.
The affected units were distributed worldwide, including the United States (all 50 states), France, Canada, Puerto Rico, Guam, Great Britain, Ireland, and Australia. The source text does not specify specific actions for consumers or healthcare providers beyond the identification of the software issue.
The recalled product
- Product
- Horizon Medical Imaging It 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 various medical…
- 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 4.5
- HMI 4.6.1
- HIM 5.0
- HMI 5.0 Service Pack 6
- HMI 5.0 Service Pack 7
- HMI 5.0 Service Pack 8
- HMI 11.0.6
- HMI 11.0.6 FR EXP 2
- HMI 11.0.7
- HMI 11.0.8
- HMI 11.5
- HMI 11.5.1
- HMI 11.5.2
- HMI 11.6
- HMI 11.7
- HMI 11.8
- HMI 11.9
- MR 12.0
Distribution
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Similar recalls
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FDA (Devices) · 2014-06-18
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