Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis Q.zen biplane

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Siemens Artis Q.zen biplanesee related information
Date Initiated by FirmJune 06, 2019
Create DateJune 28, 2019
Recall Status1 Terminated 3 on February 09, 2021
Recall NumberZ-1904-2019
Recall Event ID 83082
510(K)NumberK181407 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSiemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Code Information Serial Numbers: 123049 123216 123046 123236 123211 123202 123043 123219 123240 123230 123246 
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 Commerce11
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
-
-