McKesson Medical Imaging Software Recalled for Potential Image Display Errors
McKesson is recalling Horizon Medical Imaging and Radiology software due to a design deficiency that may cause incorrect patient images to be displayed.
What this means for you
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 involves a risk-of-harm product (medical imaging software) where incorrect patient images could lead to misdiagnosis or treatment errors, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
McKesson Medical Imaging is recalling specific versions of its Horizon Medical Imaging (HMI) and McKesson Radiology (MR) software products. The affected versions include HMI 4.6.1 through 11.9, and MR 12.0 and 12.1.1. A total of 631 devices are involved in this recall.
The recall is due to a design deficiency where, under rare circumstances, imported images or studies may re-use a non-unique image directory. This issue may result in incorrect images being displayed for a patient. The products were distributed nationwide in the United States, including Puerto Rico, as well as in Guam, Great Britain, France, Canada, Ireland, and Australia.
Healthcare facilities using these software versions should contact McKesson Medical Imaging for instructions on how to resolve the issue. No specific consumer action is required for the general public, as these are professional medical devices.
The recalled product
- Product
- McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
- Manufacturer
- Mckesson Medical Immaging
- Affected units
- 631
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 (11)
- McKesson Radiology Versions- 12.1.1
- 12.0
- Horizon Medical Imaging Versions -11.9
- 11.8
- 11.7
- 11.6
- 11.5.2
- 11.5.1
- 11.0.8
- 5.0
- 4.6.1
Distribution
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