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).
This recall has been terminated (originally issued August 22, 2012).
- Recall Initiated
- May 29, 2012
- Posted
- August 22, 2012
- Terminated
- September 12, 2013
- Recall Number
- Z-2238-2012
- Quantity
- 516 units
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential to save reports in RadReport with an Incorrect Final Status.
Distribution
Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
Lot / Code Info
Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.
Root Cause
Software design
Action Taken
McKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.