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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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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
Distribution Pattern U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.

Product Detail

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