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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ARTIS Q.zen

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 Class 2 Device Recall Siemens ARTIS Q.zensee related information
Date Initiated by FirmOctober 19, 2018
Create DateNovember 14, 2018
Recall Status1 Terminated 3 on April 27, 2020
Recall NumberZ-0459-2019
Recall Event ID 81514
510(K)NumberK123529 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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 zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
Code Information Serial Numbers: Serial 123202 123211 123208 123209 123206 123207 123219 123205 123201 123055 123056 123216 123200 123212 
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		Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
FDA Determined
Cause 2		Device Design
ActionSiemens issued on 10/19/18 an Urgent Medial Devoce Correction notification to via AX033/18/S advising users of the problem, health risk, steps to be taken. Siemens has initiated screw connection exchange of the ceiling bearing via Update Instruction AXOSS/17 /S.
Quantity in Commerce15
DistributionUS Nationwide Distribution
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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