ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ARTIS Icono biplane - model # 11327600 ARTIS Icono Floor - model # 11327700 Serial numbers: 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 21) 180053 22) 180054 23) 180055 24) 180057 25) 180060 26) 180062 27) 180065 28) 180066 29) 180067 30) 180068 31) 180070 ***Updated 11/6/2020*** 180072
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS 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.
Product Codes/Lot Numbers:
ARTIS Icono biplane - model # 11327600 ARTIS Icono Floor - model # 11327700 Serial numbers: 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 21) 180053 22) 180054 23) 180055 24) 180057 25) 180060 26) 180062 27) 180065 28) 180066 29) 180067 30) 180068 31) 180070 ***Updated 11/6/2020*** 180072
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0400-2021
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.