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

Recall Z-0997-2013 — Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

U.S. FDA — Device Enforcement · United States · 2013-03-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0997-2013
Date of alert
2013-03-08
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: The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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