Recall Z-0976-2014— Mckesson Information Solutions LLC

Name: FDA recall Z-0976-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-23

Class II · Terminated

Class II FDA medical device recall by Mckesson Information Solutions LLC, initiated 2013-12-23, terminated 2017-04-25. It names one FDA 510(k) clearance: K043146. Product: Horizon Medical Imaging, Picture Archive Communication System (PACS).. Reason: 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..

Recalling firm: Mckesson Information Solutions LLC
Classification: Class II
Status: Terminated
Initiated: 2013-12-23
Terminated: 2017-04-25
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

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

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.

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