FDAClass IIApril 2, 2014

Siemens Artis Q and Artis Q biplane systems Product recall

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

Why was Siemens Artis Q and Artis Q biplane systems Product recalled?

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).

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 numbers 10848280, 10848281, 10848282, and 10848283.

Product
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
Recalling firm
Siemens Medical Solutions USA, Inc
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.
Recall date
April 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls