FDAClass IIOctober 9, 2013

McKesson Horizon Medical Imaging recall: Software Issue

McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information…

Why was McKesson Horizon Medical Imaging recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information…
Recalling firm
Mckesson Information Solutions LLC
Quantity
329 units
Distribution
Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
Recall date
October 9, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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