Device product
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
Z-2318-2013
Product summary
- Event
- Event 66301
- Status
- Terminated
- Classification
- Class II
- Quantity
- 329 units
- Official record key
device-enforcement:Z-2318-2013
Official wording
Reason: Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Code information: Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.
Distribution pattern: Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
Derived failure modes
-
Device software or design
Software malfunction