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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 Icono see related information
Date Initiated by Firm December 18, 2020
Create Date February 23, 2021
Recall Status1 Terminated 3 on November 17, 2021
Recall Number Z-1144-2021
Recall Event ID 87169
510(K)Number K193326  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product ARTIS Icono biplane Model:11327600
ARTIS Icono floor system Model: 11327700
with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
Code Information Software version VE20B. Serial Numbers: Serial 180054 180062 180019 180065 180056 180057 180041 180084 180034 180072 180060 170026 180070 180048 180083 180080 180067 180040 180029 170023 180068 170025 180018 180047 180046 180085 180035 180081 170051 170027 180043 170053 180049 180077 180053 180055 180015 180014 180066 180082 180037 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice to all affected customers via AX080/20/S. on 12/28/20. Letter states reason for recall, health risk and action to take: Siemens will provide a software update to all affected customers which will correct the issue via Update Instruction AX070/20/S. The Operator Manual addendum to the Instruction for Use for VE20 has been updated and includes the missing information about the grid indication Our service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436.
Quantity in Commerce 41 U.S
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solutions USA, Inc.
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