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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS phe

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 Class 2 Device Recall ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS phesee related information
Date Initiated by FirmMay 15, 2025
Date PostedJune 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2022-2025
Recall Event ID 97135
510(K)NumberK241572 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Productinterventional fluoroscopic x-ray system
Code Information 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		In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionSiemens Healthineers sent customers a Customer Advisory Notice dated May 15, 2025 informing customers of a potential issue with ARTIS pheno and ARTIS icono systems with the following model numbers: ARTIS pheno 10849000, ARTIS icono biplane 11327600, ARTIS icono ceiling 11328100, ARTIS icono floor 11327700; due to in very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose and appropriate software update will be implemented, based on the current software version of the affected system.
DistributionWorldwide.
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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