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.
This recall has been terminated (originally issued September 30, 2013).
- Recall Initiated
- September 4, 2013
- Posted
- September 30, 2013
- Terminated
- February 6, 2017
- Recall Number
- Z-2318-2013
- Quantity
- 329 units
- Firm Location
- Information Technology Business Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Distribution
Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
Lot / Code Info
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.
Root Cause
Software change control
Action Taken
Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.