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Recall Observatory FDA recall evidence

Device product

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Z-1288-2021

February 26, 2021

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 87479
Status
Terminated
Classification
Class II
Quantity
29 systems
Official record key
device-enforcement:Z-1288-2021

Official wording

Reason: Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

Code information: ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700

Distribution pattern: US Nationwide distribution in the states of MI, KY, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.