FDA Recall Terminated

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.

Recall: Z-3035-2011 · Initiated February 2, 2011

Recall

Recall Number
Z-3035-2011
Event Number
59365
Firm
Mckesson Information Solutions LLC
FEI Number
3002684279
Product Code
LLZ
Status
Terminated
Root Cause
Other
Initiated
February 2, 2011
Posted
August 18, 2011
Terminated
October 4, 2012
Address
5995 Winward Plaza, Information Technology Business Alpharetta, GA, 30005

Description

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.

Reason

Images for one patient may appear in the study of another patient.

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 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.

Distribution

Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the United Kingdom.

Quantity

438 devices