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Recall Observatory FDA recall evidence

Device product

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.

Z-2318-2013

September 04, 2013

Class II

Product summary

Firm
Mckesson Information Solutions LLC
Event
Event 66301
Status
Terminated
Classification
Class II
Quantity
329 units
Official record key
device-enforcement:Z-2318-2013

Official wording

Reason: Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.

Code information: Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6.

Distribution pattern: Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software malfunction