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

Recall Z-1647-2022 — Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

U.S. FDA — Device Enforcement · United States · 2022-08-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1647-2022
Date of alert
2022-08-10
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)
11327600
Reported risk: Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.