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

Recall Z-2524-2018 — ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

U.S. FDA — Device Enforcement · United States · 2018-05-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2524-2018
Date of alert
2018-05-30
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: During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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