Reported Feb 2, 2022 · Terminated
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
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?
- Artis icono biplane with software VE20C-diagnostic
- imaging angiography system Model11327600
- Lot codes and dates
- Serial Numbers
72 of 72 codes
180062180318180054180019180065180057180041180317180034180072180349180060180337180070180048180083180369180370180345180315180343180080180301180305180067180330180040180360180333180029180352180336180316180068180363180084180334180018180350180354180046180047180335180085180035180339180357180358180361180362180081180331180021180342180321180309180356180368180341180323
- UDI04056869063317
- Expanded Recall 12/20/21 S/N180056
- Serial Numbers
- Amount recalled
- 72 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
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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