Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno recall
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Why was Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 5602
- Distribution
- Worldwide-US Nationwide
- Recall date
- January 20, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)