Recall Z-2121-2014— Mckesson Medical Immaging

Name: FDA recall Z-2121-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-05

Class II · Terminated

Class II FDA medical device recall by Mckesson Medical Immaging, initiated 2014-05-05, terminated 2017-04-13. It names one FDA 510(k) clearance: K043146. Product: Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.. Reason: The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images..

Recalling firm: Mckesson Medical Immaging
Classification: Class II
Status: Terminated
Initiated: 2014-05-05
Terminated: 2017-04-13
Firm location: Richmond, British Columbia, Canada

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

Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

Reason for recall

The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.

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