Siemens Medical Solutions USA, Inc Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700 Recall
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 SMN: 11327700
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053
Siemens Medical Solutions USA, Inc is recalling Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interv due to if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cau. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Recommended Action
Per FDA guidance
Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via AX027/21/S on 4/11/22. Siemens will conduct an inspection of the protective earth via Update Instruction AX026/21/S. 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. Acknowledge Receipt of this Safety Advisory Notice 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