Recall Z-3035-2011 ยท LLZ System, Image Processing, Radiological
Mckesson Information Solutions LLC
Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. 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 imaging systems.
| Date | Aug 18, 2011 (initiated Feb 2, 2011) |
| Status | Terminated |
| Reason | Images for one patient may appear in the study of another patient. |
| Root cause | Other |
| Action | Mckesson Medical Imaging Group sent a URGENT FIELD SAFETY NOTICE letter dated June 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On February 2, 2011, the McKesson Medical Imaging company initiated a process for applying an image display software update to the HMI systems at the hospital site that initiated the complaint. They were advised to contact McKesson Customer Support at 1-800-663-2533, to indicate whether they would like to receive the software update. They were advised to distribute the noti |
| Quantity | 438 devices |
| Distribution | Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the 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 |