Horizon Medical Imaging, Picture Archive Communication System (PACS).
FDA Recall #Z-0976-2014 — Class II — December 23, 2013
Product Description
Horizon Medical Imaging, Picture Archive Communication System (PACS).
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.
Recalling Firm
Mckesson Information Solutions LLC — Alpharetta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
618 units
Distribution
U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated