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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS Icono

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 Class 2 Device Recall ARTIS Iconosee related information
Date Initiated by FirmFebruary 26, 2021
Create DateMarch 22, 2021
Recall Status1 Terminated 3 on August 11, 2021
Recall NumberZ-1288-2021
Recall Event ID 87479
510(K)NumberK193326 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductInterventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Code Information ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information ContactMeredith Adams
610-448-6478
Manufacturer Reason
for Recall		Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
FDA Determined
Cause 2		Component design/selection
ActionOn 2/26/2021, Siemens issued an Urgent Medical Device Correction notice to in inform customers of a possible hazard to patients, operators, or other persons and equipment due to a hardware error which affects ARTIS icono /pheno systems in combination with imaging system UPS (Uninterrupted Power Supply) option. This potential hardware issue has no influence on the previous treatment/diagnosis of patients. However, in case of error, planned procedures may have to be terminated and performed on an alternative x-ray system. Based on our investigation, you can continue to safely use your system.
Quantity in Commerce29 systems
DistributionUS Nationwide distribution in the states of MI, KY, TX.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = OWB
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