Reported Jun 15, 2022 · Ongoing
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional…
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 -angiography systems developed for single and biplane diagnostic imaging
- and interventional procedures SMN11327600
- Lot codes and dates
- UDI-DI04056869063317
- Serial Number
180062180054180019180065180056180057180041180317180034180072180060180070180048180083180315180080180301180305180067180330180040180333180029180336180316180084180334180018180046180047180335180085180035180081180331180021180321180309180323180329180043180049180077180086180053180055180015180014180066180082180037
- Amount recalled
- 51 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
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
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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