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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis zee/zeego & Artis Q/Q.zen

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  Class 2 Device Recall Siemens Artis zee/zeego & Artis Q/Q.zen see related information
Date Initiated by Firm April 30, 2020
Create Date June 09, 2020
Recall Status1 Terminated 3 on September 11, 2020
Recall Number Z-2302-2020
Recall Event ID 85647
510(K)Number K181407  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows:

Artis Q floor Model: 10848280;
Artis Q ceiling Model: 10848281;
Artis Q biplane Model:10848282;
Artis zee ceiling Model: 10094137;
Artis zee floor Model: 10094135

Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Code Information Serial Numbers: Serial 125253 103340 121526 121521 103335 109621 138311 148418 147237 109620 136555 121520 121525 121518 125254 
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		 Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens Healthineers issued Urgent Medical Device Correction via AX036/19/S, dated 4/30/20, letter states reason for recall, health risk, and action to take: Siemens will exchange the affected power distributor of the Multi Display Manager. We advise you not to move the Multi Display Manager Container or to open the power distributor before the corrective action can be completed. A service organization will contact you to schedule an appointment to perform the correction via Update Instruction AX035/19/S. Please feel free to contact service organization at 1-800-888-7436 for an earlier appointment. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented; Acknowledge Receipt of this Safety Advisory Notice, By signing this document, you are acknowledging that you have read and understand the content therein.
Quantity in Commerce 15 US
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 Solution USA, Inc.
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