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

Recall Z-1824-2017 — Artis zee, Angiographic x-ray system

U.S. FDA — Device Enforcement · United States · 2017-03-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1824-2017
Date of alert
2017-03-28
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)
10280959
Reported risk: Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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