Recall Z-1534-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1534-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-22

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-02-22, terminated 2017-10-24. It names one FDA 510(k) clearance: K123529. Product: ARTIS Q, Interventional Fluroscopic x-ray system. Reason: In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-02-22
Terminated: 2017-10-24
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

ARTIS Q, Interventional Fluroscopic x-ray system

Reason for recall

In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

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