Recall Z-1309-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1309-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-07

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-02-07, terminated 2015-03-16. It names one FDA 510(k) clearance: K073290. Product: Artis Zee Angiographic x-ray systems.. Reason: An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Terminated: 2015-03-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K073290 — ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc.·cleared 2008-02-11

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

Artis Zee Angiographic x-ray systems.

Reason for recall

An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.

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