—#124517

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123529
Affected lot / code info: model numbers 10848280, 10848281, 10848282, and 10848283.

Why it was 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).

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an Important Customer Safety Notice letter dated November 22, 2013, to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to discontinue use until the affected product has been successfully replaced by a Siemen's representative.at no cost.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

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

Timeline

Recall initiated: 2013-12-05
Posted by FDA: 2014-03-27
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.