Recall Z-2318-2013— Mckesson Information Solutions LLC

Name: FDA recall Z-2318-2013
Creator: U.S. Food and Drug Administration
Published: 2013-09-04

Class II · Terminated

Class II FDA medical device recall by Mckesson Information Solutions LLC, initiated 2013-09-04, terminated 2017-02-06. It names one FDA 510(k) clearance: K043146. Product: McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.. Reason: Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss..

Recalling firm: Mckesson Information Solutions LLC
Classification: Class II
Status: Terminated
Initiated: 2013-09-04
Terminated: 2017-02-06
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K043146 — HORIZON MEDICAL IMAGINGMckesson Medical Imaging Company·cleared 2005-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

Reason for recall

Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.

Data sourced from openFDA. This site is unofficial and independent of the FDA.