Recall Z-1468-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1468-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-27

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-02-27, terminated 2019-01-14. It names one FDA 510(k) clearance: K052202. Product: Axiom Artis fluoroscopic x-ray system. Reason: A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-02-27
Terminated: 2019-01-14
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K052202 — AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2006-03-07

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

Axiom Artis fluoroscopic x-ray system

Reason for recall

A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.

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