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.
FDA Recall Z-3035-2011 · Posted 2011-08-18
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Recalling FirmMckesson Information Solutions LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-02-02
Date Terminated2012-10-04
Product Quantity438 devices
Reason for Recall
Images for one patient may appear in the study of another patient.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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