Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Reported: January 20, 2021 Initiated: November 30, 2020 #Z-0656-2021
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 5602
- Distribution
- Worldwide-US Nationwide
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 5602.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0656-2021.
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