Recall Z-2238-2012 ยท LLZ System, Image Processing, Radiological
Mckesson Medical Imaging Group
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 a
| Date | Aug 22, 2012 (initiated May 29, 2012) |
| Status | Terminated |
| Reason | There is a potential to save reports in RadReport with an Incorrect Final Status. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 516 units |
| Distribution | Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043146 | HORIZON MEDICAL IMAGING Mckesson Medical Imaging Company, Jan 4, 2005 |