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U.S. Department of Health and Human Services

Class 2 Device Recall Artis Zee/Zeego & Artis Q/Q.Zen

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  Class 2 Device Recall Artis Zee/Zeego & Artis Q/Q.Zen see related information
Date Initiated by Firm October 20, 2021
Create Date November 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-0297-2022
Recall Event ID 88962
510(K)Number K181407  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure
Model Number:10094137
Code Information Serial Numbers: Serial 150002 150017 125700 150005 150023 150009 150015 150003 Expanded Recall 11/15/21: 147120 147119 150011 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice dated 10/202/1 to customers via AX070/21/S, Siemens will update the system software via Update Instruction AX069/21/S. Letter states reason for recall, health risk and action to take: To avoid the problem, it is recommended to position the SID first and then release x-ray. Siemens will correct the software error (software VD12) via Update Instruction AX069/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. We do not consider it necessary to re-examine any patients in relation to the issues described above. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Quantity in Commerce 8 units
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 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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