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

Recall Z-0656-2021 — Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

U.S. FDA — Device Enforcement · United States · 2020-11-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0656-2021
Date of alert
2020-11-30
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)
10094135
Reported risk: When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.
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.