FDAFDA · Food and drugs·Recall number Z-0976-2014
Horizon Medical Imaging, Picture Archive Communication System (PACS).
Published February 19, 2014 · Recall initiated: December 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mckesson Information Solutions LLC
- Distributor
- U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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