FDAFDA · Food and drugs·Recall number Z-2318-2013
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.
Published October 9, 2013 · Recall initiated: September 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mckesson Information Solutions LLC
- Distributor
- Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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