Recall Z-1202-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1202-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-05

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-12-05, terminated 2014-11-06. It names one FDA 510(k) clearance: K123529. Product: Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray. Reason: There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40)..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-05
Terminated: 2014-11-06
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123529 — ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2013-02-26

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 Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray

Reason for recall

There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).

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