Reported Jul 13, 2022 · Ongoing
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows
3 of 3 products
| Model / number | Product as published |
|---|---|
10849000 | (2) Artis icono biplane |
11327600 | (3) Artis icono floor |
11327700 | — |
- Lot codes and dates
- (1)Artis
- Pheno UDI-DI04056869046877 (2)Artis
- icono biplane UDI-DI04056869063317 (3)
- Artis icono floor- UDI-DI04056869149325
- S/NSerial
127 of 127 codes
170319180062180054180019164719164712180065180056180057180041180421180317180034164740180349180301164722180367180382180060164311170026180337164763180070180048180083164735180087180370180371180372180345180315170367170368164723180343180080180305180330170331164743180379180386164741180360180333170349170361180029180352180336180407164728180412180400180397180316180068
- Amount recalled
- 127 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
This product could cause temporary or reversible health problems — stop using it.
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