McKesson Horizon Medical Imaging System Recalled for Incorrect Report Status
McKesson Medical Imaging Group is recalling Horizon Medical Imaging systems because reports may be saved with an incorrect final status.
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. The hazard involves a software defect leading to incorrect report status, which is a data integrity issue rather than a direct physical injury risk. No injuries or illnesses are reported in the source text.
Plain-English summary
McKesson Medical Imaging Group is recalling 516 units of the Horizon Medical Imaging system. The recall affects versions 11.5, 11.5.1, 11.5.2, 11.6, and 11.7. The system is a medical image and information management application intended to receive, transmit, store, retrieve, display, print, and process digital medical images and associated medical information.
The recall is due to a potential issue where reports in the RadReport module may be saved with an incorrect final status. This defect could impact the accuracy of the medical information managed by the system.
The affected units were distributed worldwide, including the United States, Canada, France, Ireland, and the United Kingdom. McKesson Medical Imaging Group is the recalling firm.
The recalled product
- Product
- Horizon Medical Imaging system. Product Usage: 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…
- Manufacturer
- Mckesson Medical Imaging Group
- Affected units
- 516
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 (4)
- Horizon Medical Imaging (HMI) versions 11.5
- 11.5.1
- 11.5.2
- 11.6 and 11.7.
Distribution
Distributed nationwide across the United States.
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