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.
Recall
- Recall Number
- Z-2121-2014
- Event Number
- 68799
- Firm
- Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia
- FEI Number
- 3003757840
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 5, 2014
- Posted
- July 28, 2014
- Terminated
- April 13, 2017
Description
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.
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.
McKesson sent an Urgent Field Safety Notice dated May 5, 2014, to all affected customers informing them of the issue and advising them of the immediate actions to take to reduce the risk to the patient. These actions include - Users ensure that all expected images are display in the Image Viewer and PACS Administrators should engage McKesson Support for all issues with studies. McKesson is also providing a software solution to HMI systems that may be potentially affected by the problem to prevent future recurrence. Customers were instructed to contact McKesson Support as soon as possible at 1-800-663-2533 to acknowledge that they have read and understood the Field Safety Notice, and to arrange installation of the software update. Customers with questions were instructed to contact Customer Support and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.
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.
659 units