Z-0976-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2014
- Initiation Date
- December 23, 2013
- Termination Date
- April 25, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 618 units
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.
Distribution Pattern
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.