Siemens Medical Solutions USA, Inc Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700
Products Sold
ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700
Siemens Medical Solutions USA, Inc is recalling Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnosti due to Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
Recommended Action
Per FDA guidance
On 2/26/2021, Siemens issued an Urgent Medical Device Correction notice to in inform customers of a possible hazard to patients, operators, or other persons and equipment due to a hardware error which affects ARTIS icono /pheno systems in combination with imaging system UPS (Uninterrupted Power Supply) option. This potential hardware issue has no influence on the previous treatment/diagnosis of patients. However, in case of error, planned procedures may have to be terminated and performed on an alternative x-ray system. Based on our investigation, you can continue to safely use your system.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026