FDAFDA · Food and drugs·Recall number Z-2121-2014
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Published August 6, 2014 · Recall initiated: May 5, 2014
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
The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mckesson Medical Immaging
- Distributor
- Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY,and France, Canada, Puerto Rico, Guam, Great Britain, Ireland, Australia.
- Lot
- HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, MR 12.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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