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Open, Classified

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

FDA Recall Z-0656-2021 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2020-11-30
Product Quantity5602

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Worldwide-US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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