FDA recall Z-0656-2021

Siemens Medical Solutions USA, Inc · Class II · device

Product

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

Worldwide-US Nationwide

Key facts

Status: Ongoing
Initiation date: 2020-11-30
Report date: 2021-01-20
Voluntary/Mandated: FDA Mandated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0656-2021