McKesson Radiology Software Recalled for Missing STAT Priority Icon
McKesson Medical Imaging Group is recalling McKesson Radiology software versions 12.1.1 and 12.2 because the STAT priority icon was not displayed in the Study List when a study was opened.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a software display issue (missing icon) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
McKesson Medical Imaging Group is recalling McKesson Radiology (MR) software, versions 12.1.1 and 12.2. McKesson Radiology is a Picture Archiving Communication System (PACS) 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 STAT priority icon was not displayed in the Study List when the study was opened. This defect could potentially affect the visibility of urgent studies within the software interface.
The recall affects 164 devices. The software was distributed worldwide, including in the United States (AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WV, WI, WY) and internationally to Canada, France, Great Britain, and Ireland. Users of the affected software versions should contact McKesson Medical Imaging Group for further instructions regarding the recall.
The recalled product
- Product
- McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital…
- Manufacturer
- Mckesson Medical Imaging Group
- Category
- Medical Device — Software
- Affected units
- 164
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)
- McKesson Radiology versions 12.1.1 and 12.2
Distribution
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