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U.S. Department of Health and Human Services

Class 2 Device Recall Interventional fluoroscopic xray system

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 Class 2 Device Recall Interventional fluoroscopic xray systemsee related information
Date Initiated by FirmMarch 10, 2026
Date PostedApril 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1653-2026
Recall Event ID 98675
510(K)NumberK241572 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Code Information ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact
610-219-4834
Manufacturer Reason
for Recall		During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionSiemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice, dated March 9, 2026, to all affected customers.
Quantity in CommerceU.S. 758, OUS 2077
DistributionWorldwide - US Nationwide distribution.
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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