Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
This recall is currently active, issued November 30, 2020. It was issued by Siemens Medical Solutions Usa, Inc.
- Recall Initiated
- November 30, 2020
- Recall Number
- Z-0656-2021
- Quantity
- 5602
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide-US Nationwide
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
Root Cause
Software design
Action Taken
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.