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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis Q.zen ceiling

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 Class 2 Device Recall Siemens Artis Q.zen ceilingsee related information
Date Initiated by FirmJune 06, 2019
Create DateJune 28, 2019
Recall Status1 Terminated 3 on February 09, 2021
Recall NumberZ-1903-2019
Recall Event ID 83082
510(K)NumberK181407 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSiemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Code Information Serial Numbers: 111005 111000 111002 111125 111123 111109 111128 111124 111122 111104 111106 111121 111127 111137 111135 
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, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
FDA Determined
Cause 2		Device Design
ActionSiemens issued letter dated 6/6/19 advising of the problem, health risk and action to take: .Siemens is implementing a corrective action to all potentially affected users via Update Instruction AX023/18/S. Siemens Service organization will replace the screwed connection of the ceiling support according to specifications / instructions. In the event the bolt connection cannot be replaced due to technical conditions, the complete bearing will be replaced.
Quantity in Commerce15
DistributionNationwide
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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