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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zeego and Artis Q.zeego

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  Class 2 Device Recall Artis zeego and Artis Q.zeego see related information
Date Initiated by Firm May 24, 2022
Create Date July 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-1343-2022
Recall Event ID 90407
510(K)Number K181407  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Code Information UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-448-6478
Manufacturer Reason
for Recall		 It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.
FDA Determined
Cause 2		 Component design/selection
Action On May 24, 2022, the firm mailed Urgent Medical Device Correction letters to affected consignees. Customers were informed that if the system is not used regularly, please ensure that the system is switched on in due time before any use to check the status. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. The firm will replace the Bios battery and the service interval will be shortened to two years. The firm will contact customers to arrange a date to perform the correction. Customers may call the service organization at 1-800-888-7435 to schedule an earlier appointment.
Quantity in Commerce 233 worldwide; 32 US
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, FL, IL, LA, ME, MN, MO, NC, OH, PA, SC, TN, TX, WI and the countries of Australia, Austria, Azerbaijan, Belgium, Canada, China, Finland, France, Germany, Hong Kong, India, Italy, Japan, Lebanon, Lithuania, Luxembourg, Netherlands, Poland, Portugal, South Korea, Switzerland, United Kingdom.
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 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) Database 510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solution USA, Inc.
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