FDAFDA · Food and drugs·Recall number Z-2238-2012
Horizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Published August 29, 2012 · Recall initiated: May 29, 2012
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
There is a potential to save reports in RadReport with an Incorrect Final Status.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mckesson Medical Imaging Group
- Distributor
- Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
- Lot
- Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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