device · product 1 of 1
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).
- Recall number
- Z-2238-2012
- Initiated
- May 29, 2012
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Mckesson Medical Imaging Group
- Quantity
- 516 units
App-derived interpretation
There is a potential to save reports in RadReport with an Incorrect Final Status.
Official device-enrichment evidence · Sourced
Software design
Inspect official wording and provenance
Reason for recall
There is a potential to save reports in RadReport with an Incorrect Final Status.
Code information
Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
Distribution pattern
Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.