—#185060

Product

Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181407
Affected lot / code info: Model number: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Pheno- 10849000 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q biplane- 10848282 Artis Q zeego- 10848283 Artis Q.zen floor- 10848353 Artis Q.zen ceiling- 10848354 Artis Q.zen biplane- 10848355

Why it was recalled

When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro "Fluoro Override", the measured Air Kerma Rate can exceed the regulatory limits.

Root cause (FDA determination)

Software design

Action the firm took

Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers via AX067/20/P on November 30, 2020. All modifications and repairs are provided to affected customers free of charge.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Worldwide-US Nationwide

Timeline

Recall initiated: 2020-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185060. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.