McKesson Radiology PACS Software Recall for Potential Missing Images
McKesson Medical Imaging is recalling McKesson Radiology 12.2 PACS software due to a defect that may cause missing images or stuck imports.
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 hazard involves a software defect that may lead to missing medical images, which is a significant functional issue but does not involve direct physical injury or death.
Plain-English summary
McKesson Medical Imaging is recalling 17 units of the McKesson Radiology 12.2 Picture Archive Communication System (PACS) software. The recall is due to a software issue affecting customers who use an EMR login or legacy web URL login.
The defect may result in missing images in newly imported studies or cause study imports to remain in an "in-progress" status. The affected software was distributed in Alaska, California, Florida, Hawaii, Kentucky, Maryland, Michigan, Mississippi, New Hampshire, Ohio, Pennsylvania, Tennessee, Texas, and Vermont.
Customers using the affected software should contact McKesson Medical Imaging for further instructions regarding the recall and potential software updates.
The recalled product
- Product
- McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
- Manufacturer
- Mckesson Medical Imaging
- Category
- Medical Device — Software
- Affected units
- 17
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 12.2
Distribution
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