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Terminated

Artis Q and Q.Zen fluoroscopic x-ray system

FDA Recall Z-1466-2017 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-02-27
Date Terminated2019-01-14
Product Quantity2,158 units distributed in US and 6,139 units worldwide

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.

Firm Action

A Customer Safety Advisory Notice (CSAN) was mailed to affected customers on 02/27/2017 to inform them of the issue. The notice provided information on what actions to take should the foot switch fail to function, the risks involved and what corrective actions they are taking to fix the issue.

Root Cause

Process control

Distribution Pattern

Distributed Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123529ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc. · 2013-02-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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