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

Recall Z-2887-2020 — Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

U.S. FDA — Device Enforcement · United States · 2020-07-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2887-2020
Date of alert
2020-07-30
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)
10308191
Reported risk: Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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