FDAFDA · Food and drugs·Recall number Z-1728-2014
Horizon Medical Imaging Horizon Medical Imaging 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 June 18, 2014 · Recall initiated: May 29, 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
Firm received a complaint that an unreported study performed that day could not be opened from the archive.
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, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
- Lot
- HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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