PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 2, 2014 Initiated: December 5, 2013 #Z-1202-2014

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).

Details

Units Affected
19
Distribution
USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 19.
Why was this 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).
Which agency issued this recall?
This recall was issued by the FDA Devices on April 2, 2014. Severity: Moderate. Recall number: Z-1202-2014.