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Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray

FDA Recall #Z-1202-2014 — Class II — December 5, 2013

Recall #Z-1202-2014 Date: December 5, 2013 Classification: Class II Status: Terminated

Product Description

Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray

Reason for Recall

There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).

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

19

Distribution

USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.

Code Information

model numbers 10848280, 10848281, 10848282, and 10848283.

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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