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.
This recall has been terminated (originally issued August 18, 2011).
- Recall Initiated
- February 2, 2011
- Posted
- August 18, 2011
- Terminated
- October 4, 2012
- Recall Number
- Z-3035-2011
- Quantity
- 438 devices
- Firm Location
- Information Technology Business Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Images for one patient may appear in the study of another patient.
Distribution
Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the United Kingdom.
Lot / Code Info
Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8
Root Cause
Other
Action Taken
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 notification to all those within their organization who need to be aware and to alert other parties affiliated with their organization that are affected by this advisory notice.