medical Class II Updated 2020-01-22

Siemens Medical Solutions USA, Inc recalls Siemens ARTIS pheno, Model # 10849000. Interventional Fluor

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
View official government recall

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