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Terminated

CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

FDA Recall Z-1281-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2016-02-16
Date Terminated2017-11-08
Product Quantity4 units

Reason for Recall

Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.

Firm Action

Siemens sent a Customer Safety Advisory Notice dated February 18, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that Siemens is planning to replace the affected parts as a precautionary measure. A Siemens service engineer will contact each customer to schedule implementation of this precautionary measure.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distributed in the states of AR, CA, NE and UT

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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