FDA Device recall Z-0400-2021

ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems deve…

FDA Device
Class II
terminated
Published 2020-11-11

On 2020-11-11 the FDA classified a Class II recall of ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems deve… by Siemens Medical Solutions Usa, citing 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 h….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0400-2021
Classification	Class II
Status	terminated
Initiated	2020-09-18
Published	2020-11-11
Last updated	2026-09-13 11:55 UTC
Company	Siemens Medical Solutions Usa
Distribution	US

Product

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.

Reason

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.

Identifiers

code_info	ARTIS Icono biplane - model # 11327600 ARTIS Icono Floor - model # 11327700 Serial numbers: 1) 170023 2) 170025… 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

code_info

ARTIS Icono biplane - model # 11327600 ARTIS Icono Floor - model # 11327700 Serial numbers: 1) 170023 2) 170025…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0400-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.