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Recall Observatory FDA recall evidence

Device product

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Z-0807-2020

December 20, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 84648
Status
Terminated
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-0807-2020

Official wording

Reason: The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

Code information: Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244

Distribution pattern: US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.