Siemens Medical Solutions USA, Inc ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
UDI-DI: 4056869149325 Serial Numbers: 170561 170549 170559 170546 170552 170571 170570
Products Sold
UDI-DI: 4056869149325 Serial Numbers: 170561 170549 170559 170546 170552 170571 170570
Siemens Medical Solutions USA, Inc is recalling ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interv due to Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Recommended Action
Per FDA guidance
Siemens issued Urgent: Medical Device Correction to all users of ARTIS icono/ ARTIS pheno systems with a specific Polydoros ACX power generator on 6/19/23. Letter states reason for recall, health risk and action to take: It is strongly recommended to establish appropriate emergency procedures until the corrective action has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the hardware error via Update Instruction AX008/23/S. This measure will correct the Polydoros ACX reactor coil of all affected systems. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
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