Recall Z-1396-2017— Mckesson Medical Imaging

Name: FDA recall Z-1396-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-02

Class II · Terminated

Class II FDA medical device recall by Mckesson Medical Imaging, initiated 2016-12-02, terminated 2017-11-24. It names one FDA 510(k) clearance: K140909. Product: McKesson Radiology 12.2 - Picture Archive Communication System (PACS). Reason: Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status..

Recalling firm: Mckesson Medical Imaging
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Terminated: 2017-11-24
Firm location: Richmond, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K140909 — MCKESSON RADIOLOGYMckesson Medical Imaging Company·cleared 2014-07-02

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 Radiology 12.2 - Picture Archive Communication System (PACS)

Reason for recall

Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status.

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