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Recall Observatory FDA recall evidence

Device product

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

Z-1202-2014

December 05, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67016
Status
Terminated
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-1202-2014

Official wording

Reason: 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).

Code information: model numbers 10848280, 10848281, 10848282, and 10848283.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).