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 Axiom Iconos R200

  • 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 Axiom Iconos R200see related information
Date Initiated by FirmJanuary 29, 2010
Date PostedMarch 27, 2010
Recall Status1 Terminated 3 on August 11, 2010
Recall NumberZ-1213-2010
Recall Event ID 54616
510(K)NumberK992660 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
ProductAxiom Iconos R200 X-Ray
Code Information Model numbers 10093961, 5902767, 5902775, 5902783, 5902791, 5904086, 7152460, and 7152478
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactTechnical Support
888-826-9702
Manufacturer Reason
for Recall		table can tilt/move when it is not intended
FDA Determined
Cause 2		Software design
ActionThe recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.
Quantity in Commerce169 units
DistributionNationwide 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 = JAA
-
-