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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.zensee related information
Date Initiated by FirmJuly 30, 2019
Create DateAugust 24, 2019
Recall Status1 Terminated 3 on April 29, 2020
Recall NumberZ-2367-2019
Recall Event ID 83565
510(K)NumberK181407 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductArtis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281; Artis Q zeego 10848283 ArtisQ.zen ceiling 10848354 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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. The Artis family can also support the acquisition of position triggered imaging for spatial data synthesis.
Code Information Serial Numbers: 123245 103302 121501 148401 109589 148393 111129 148400 103310 148397 155235 121505 109563 121506 131235 121502 105125 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts
FDA Determined
Cause 2		Process control
ActionSiemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (AX011/19/S) on 8/1/19 a . The letter identifies the reason for recall, health risk and action to take: Siemens Service organization will inspect the table mainframe for possible cracks and will contact you shortly to arrange a date to perform this corrective action. Contact the service organization for an earlier appointment at 1-800-888-7436.
Quantity in CommerceUS 17
DistributionUS Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI
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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