McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.
FDA Recall Z-2318-2013 · Posted 2013-09-30
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Recalling FirmMckesson Information Solutions LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-09-04
Date Terminated2017-02-06
Product Quantity329 units
Reason for Recall
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Firm Action
Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
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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