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 zee floor

  • 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 zee floorsee related information
Date Initiated by FirmJune 06, 2019
Create DateJune 28, 2019
Recall Status1 Terminated 3 on February 09, 2021
Recall NumberZ-1894-2019
Recall Event ID 83082
510(K)NumberK181407 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductSiemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Code Information Serial Numbers: 135954 136032 136077 136043 136190 136197 136168 136143 136234 136383 136242 136393 136128 136147 136350 136256 136314 136548 136550 136557 136558 137165 137119 136607 137388 137231 137471 137591 137245 137369 137347 137329 137391 137479 137425 124006 138061 137461 137518 137567 137582 137667 137595 137656 138104 138190 124116 137714 124119 138012 138070 138017 138058 138194 138156 138214 138128 138180 138188 138260 138268 138311 138259 
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 Commerce63
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
-
-