Recall Z-1182-2016— Mckesson Medical Immaging

Name: FDA recall Z-1182-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-18

Class II · Terminated

Class II FDA medical device recall by Mckesson Medical Immaging, initiated 2016-02-18, terminated 2018-08-28. It names one FDA 510(k) clearance: K043146. Product: McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.. Reason: McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient..

Recalling firm: Mckesson Medical Immaging
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Terminated: 2018-08-28
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

McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.

Reason for recall

McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.

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