Z-0656-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- November 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 5602
Product Description
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
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 Pattern
Worldwide-US Nationwide
Code Information
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