Recall Z-1080-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1080-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-16

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-12-16, terminated 2015-03-09. It names one FDA 510(k) clearance: K073290. Product: Siemens Artis zee Ceiling Systems. Angiographic x-ray system.. Reason: During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-16
Terminated: 2015-03-09
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

Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

Reason for recall

During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

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