ClearanceBrief
Recall Z-0976-2014 ยท LLZ System, Image Processing, Radiological

Mckesson Information Solutions LLC

Horizon Medical Imaging, Picture Archive Communication System (PACS).

DateFeb 12, 2014 (initiated Dec 23, 2013)
StatusTerminated
ReasonImages 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.
Root causeSoftware design
ActionMcKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
Quantity618 units
DistributionU.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K043146HORIZON MEDICAL IMAGING
Mckesson Medical Imaging Company, Jan 4, 2005