McKesson Recalls Horizon Medical Imaging PACS Software Due to Archive Errors
McKesson Information Solutions LLC is recalling 618 units of Horizon Medical Imaging PACS software because images may be archived to incorrect locations, causing display failures.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical imaging software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
McKesson Information Solutions LLC is recalling 618 units of the Horizon Medical Imaging, Picture Archive Communication System (PACS) software. The recall affects specific software versions, including HMI 4.5, HMI 4.6.6, HMI 5, HMI 11.0, HMI 11.5, HMI 11.6, HMI 11.7, HMI 11.8, and HMI 11.9.
The recall was issued because images may be archived to an incorrect or invalid archive location. This defect can result in incorrect images or no images being displayed for a study following retrieval from the archive.
The affected units were distributed in the United States (including Puerto Rico), Australia, Canada, France, Guam, Ireland, and the United Kingdom. Users of the affected software versions should contact McKesson Information Solutions LLC for further instructions.
The recalled product
- Product
- Horizon Medical Imaging, Picture Archive Communication System (PACS).
- Manufacturer
- Mckesson Information Solutions LLC
- Category
- Medical Device — Software
- Affected units
- 618
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 (17)
- HMI 4.5
- HMI 4.6.6
- HMI5 (Service Pack 1
- 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 11.5.1
- 11.5.2)
- HMI 11.6
- HMI 11.7
- HMI 11.8 and HMI 11.9.
Distribution
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