High FDA (Devices)·Z-2318-2013·Announced 2013-10-09

McKesson Horizon Medical Imaging System Recalled for Potential Image Loss

McKesson Information Solutions LLC is recalling Horizon Medical Imaging software versions 4.6.1 to 11.6. because a server configuration malfunction may cause the loss of digital medical images.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical imaging software) where the potential loss of images could impact patient care, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

McKesson Information Solutions LLC is recalling the McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, versions 4.6.1 through 11.6. This software application is used to receive, transmit, store, retrieve, display, print, and process digital medical images and associated information from medical imaging systems.

The recall is being issued because a software malfunction may occur in certain server configurations, which has the potential to cause the loss of digital medical images. The recall covers 329 units distributed worldwide, including the United States (and territories of Guam and Puerto Rico), Canada, and France.

Healthcare facilities using these specific versions of the HMI software should contact McKesson Information Solutions LLC for instructions on how to resolve the issue and prevent potential data loss.

The recalled product

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 medi
Manufacturer: Mckesson Information Solutions LLC
Category: Medical Device — Medical Imaging Software
Hazard: data-loss
software-malfunction
Affected units: 329

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

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

Distributed in 2 states:

Same manufacturer · Mckesson Information Solutions LLC

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Same hazard · data loss