PlainRecalls
FDA Devices Moderate Class II Terminated

Artis Q and Q.Zen fluoroscopic x-ray system

Reported: March 22, 2017 Initiated: February 27, 2017 #Z-1466-2017

Product Description

Artis Q and Q.Zen 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.

Details

Units Affected
2,158 units distributed in US and 6,139 units worldwide
Distribution
Distributed Nationwide
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis Q and Q.Zen fluoroscopic x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2,158 units distributed in US and 6,139 units worldwide.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 22, 2017. Severity: Moderate. Recall number: Z-1466-2017.