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

Recall Z-1896-2019 — Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141

U.S. FDA — Device Enforcement · United States · 2019-06-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1896-2019
Date of alert
2019-06-06
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)
10094141
Reported risk: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.