FDAClass IIApril 6, 2016

Cios Alpha recall

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…

Why was Cios Alpha recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: 10308191

Product
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…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
4 units
Distribution
US Nationwide Distributed in the states of AR, CA, NE and UT
Recall date
April 6, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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