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Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

FDA Recall #Z-1080-2014 — Class II — December 16, 2013

Recall #Z-1080-2014 Date: December 16, 2013 Classification: Class II Status: Terminated

Product Description

Siemens Artis zee Ceiling Systems. Angiographic x-ray system.

Reason for Recall

During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

Recalling Firm

Siemens Medical Solutions USA, Inc — Malvern, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

284

Distribution

Nationwide Distribution.

Code Information

Artis zee Ceiling systems serial numbers from 146352 to 147617

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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