ARTIS Icono Interventional Fluoroscopic X-Ray system recall: Software Issue
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for…
Why was ARTIS Icono Interventional Fluoroscopic X-Ray system 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 100 distributed worldwide. 31 distributed nationwide in U.S.
- Distribution
- US Nationwide distribution.
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)