Class 2 Device Recall Horizon Medical Imaging, Picture Archive Communication System (PACS).

• Date Initiated by Firm: December 23, 2013
• Date Posted: February 12, 2014
• Recall Status: Terminated on April 25, 2017
• Recall Number: Z-0976-2014
• Recall Event ID: 67374
• 510(K)Number: K043146
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Horizon Medical Imaging, Picture Archive Communication System (PACS).
• Code Information: 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.
• Recalling Firm/ Manufacturer: Mckesson Information Solutions LLC; 5995 Winward Plaza; Information Technology Business; Alpharetta GA 30005
• For Additional Information Contact: Paul Sumner; 404-338-3556
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
• Quantity in Commerce: 618 units
• Distribution: U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLZ