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

Recall Z-2283-2018 — ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

U.S. FDA — Device Enforcement · United States · 2018-05-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2283-2018
Date of alert
2018-05-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10849000
Reported risk: If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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