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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description Horizon Medical Imaging, Picture Archive Communication System (PACS).
Recall Number Z-0976-2014
Classification Class II
Code Info 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 Distributed Qty 618 units
Reason For Recall 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.

Event Detail

Event Id 67374
Product Type Devices
Status Ongoing
Recalling Firm Mckesson Information Solutions LLC
City Alpharetta
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.