McKesson Radiology-PACS software recall for missing high-priority alert icon
McKesson Medical Imaging is recalling 45 units of McKesson Radiology-PACS software because the high-priority alert icon was not displayed when no Stat studies were present.
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 defect involves a software display issue where a specific alert icon is missing under certain conditions. No injuries, illnesses, or deaths are reported in the source text, and the hazard is theoretical rather than a direct physical threat, fitting the criteria for a moderate severity score.
Plain-English summary
McKesson Medical Imaging is recalling 45 units of McKesson Radiology-PACS software, model MR 12.0. This medical image and information application is intended to receive, transmit, store, retrieve, display, print, and process digital medical images and associated information from various medical imaging systems.
The recall was initiated because the high-priority alert icon was not displayed in the Study List when there were no Stat studies present. The icon is visible when studies marked as Stat priority exist in the Study List.
The affected software was distributed nationwide in the United States, including the states of AL, CA, GA, ID, IL, IA, MD, MS, MO, NE, NV, NH, NY, NC, PA, TN, TX, VT, WA, WV, and WY, as well as in Canada and France. Users should contact McKesson Medical Imaging for further instructions regarding this software defect.
The recalled product
- Product
- McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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
- Category
- Medical Device — Software
- Affected units
- 45
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 (1)
- Model MR 12.0
Distribution
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