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.
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, 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…
- 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
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