Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage:...
FDA Recall #Z-0807-2020 — Class II — December 20, 2019
Product Description
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.
Reason for Recall
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.
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Code Information
Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated