Reported Nov 11, 2020 · Terminated
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated…
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 Interventional Fluoroscopic
- X-Ray system - Product UsageIntended
- UseARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
- Lot codes and dates
31 of 31 products
Products covered by this recall # Product as published 1 170023 2 170025 3 170026 4 170027 5 180014 6 180015 7 180018 8 180019 9 180021 10 180029 11 180034 12 180035 13 180037 14 180040 15 180041 16 180043 17 180046 18 180047 19 180048 20 180049 - Amount recalled
- 100 distributed worldwide. 31 distributed nationwide in U.S.
Where it was sold
- Nationwide
Why it was recalled
There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.
This product could cause temporary or reversible health problems — stop using it.
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