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

Recall Z-0517-2022 — Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

U.S. FDA — Device Enforcement · United States · 2021-10-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0517-2022
Date of alert
2021-10-12
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)
04056869149325
Reported risk: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
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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