Reported Mar 3, 2021 · Terminated
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product…
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
Is this the product you have?
- ARTIS Icono biplane Model11327600
- ARTIS Icono floor system Model11327700 with
- software version VE20B - Product UsageIntended for single and biplane diagnostic imaging and interventional procedures
- Lot codes and dates
- Software version VE20B
- Serial NumbersSerial
180054180062180019180065180056180057180041180084180034180072180060170026180070180048180083180080180067180040180029170023180068170025180018180047180046180085180035180081170051170027180043170053180049180077180053180055180015180014180066180082180037
- Amount recalled
- 41 U.S
Where it was sold
- Nationwide
Why it was recalled
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
This product could cause temporary or reversible health problems — stop using it.
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