PlainRecalls
FDA Devices Moderate Class II Terminated

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

Reported: December 25, 2019 Initiated: November 14, 2019 #Z-0695-2020

Product Description

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

Reason for Recall

In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.

Details

Units Affected
3
Distribution
US: WA and TX International: Denmark
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 3.
Why was this product recalled?
In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 25, 2019. Severity: Moderate. Recall number: Z-0695-2020.