FDAClass IIFebruary 19, 2014

Horizon Medical Imaging recall

Horizon Medical Imaging, Picture Archive Communication System (PACS).

Why was Horizon Medical Imaging recalled?

Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.

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?

HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.

Product
Horizon Medical Imaging, Picture Archive Communication System (PACS).
Recalling firm
Mckesson Information Solutions LLC
Quantity
618 units
Distribution
U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
Recall date
February 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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