Product Wiki · Recalls · U.S. FDA — Device Enforcement

Siemens ARTIS pheno, Model # 10849000 — recall Z-0807-2020

U.S. FDA — Device Enforcement · United States · 2019-12-20 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0807-2020
Date of alert
2019-12-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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