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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS icono floor

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 Class 2 Device Recall ARTIS icono floorsee related information
Date Initiated by FirmOctober 14, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0431-2027
Recall Event ID 100163
510(K)NumberK241572 K254173 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS icono floor. Model Number: 11327700.
Code Information Model Number: 11327700. UDI-DI: 4056869149325. Serial Number: 170611. Software Versions VE40B and VE50B.
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactAnastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		Potential for loss of X-ray functionality after system startup or restart.
FDA Determined
Cause 2		Software design
ActionSiemens notified consignees on about 10/14/2026 via letter titled "CUSTOMER ADVISORY NOTICE." Consignees were instructed to consider the potential for unavailability following startup or restart when planning the clinical use of affected systems. For critical, urgent, or time-sensitive procedures, healthcare professionals should determine in advance whether an affected system is appropriate for the planned procedure and consider established contingency measures, including the availability of an alternative system or treatment pathway. These precautions should remain in place until the corrective action has been completed on the affected system. Siemens Healthineers is implementing Field Safety Corrective Action (FSCA) for affected systems. The corrective action includes a replacement of an affected component. The corrective action will be performed by Siemens Service Organization. This measure is intended to restore the affected systems to a configuration in which the described startup or restart issue is no longer expected to occur. The service organization will contact consignees to schedule an appointment to perform corrective action. The corrective action is being distributed through Update Instruction AX047/26/S. If an earlier appointment is preferred, please contact your local Siemens Healthineers service organization. Siemens is not recommending re-examination of patients. Consignees were also requested to ensure all users of affected units are made aware of the issue and requested that consignees complete and return the response form provided.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the states of CA, IA, KY, MN, NY, OH.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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