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Recall Observatory FDA recall evidence

Device product

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

Z-0695-2020

November 14, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 84370
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0695-2020

Official wording

Reason: 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.

Code information: Model Number: 10094142 Serial Number: 140422, 140423, 140430 Software Version: VC21C

Distribution pattern: US: WA and TX International: Denmark

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.