Horizon Medical Imaging, Picture Archive Communication System (PACS).
This recall has been terminated (originally issued February 12, 2014).
- Recall Initiated
- December 23, 2013
- Posted
- February 12, 2014
- Terminated
- April 25, 2017
- Recall Number
- Z-0976-2014
- Quantity
- 618 units
- Firm Location
- Information Technology Business Alpharetta, GA
- Official Source
- View on FDA website ↗
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
U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
Lot / 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.
Root Cause
Software design
Action Taken
McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
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