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 1 Device Recall InstaTrak with Multiple Dataset Navigation

  • 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 1 Device Recall InstaTrak with Multiple Dataset Navigationsee related information
Date Initiated by FirmSeptember 15, 2006
Date PostedJuly 12, 2012
Recall Status1 Terminated 3 on August 21, 2012
Recall NumberZ-1985-2012
Recall Event ID 62112
510(K)NumberK040050 
Product Classification System, image processing, radiological - Product Code LLZ
ProductInstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
Code Information IT35050P, IT35071, IT35129, IT35133, IT35134, IT35139, IT35140, IT35143P-RC, IT35144P, IT35145P-RC, IT35146, IT35147P-RC, IT35148, IT35150, IT35153P, IT35156, IT35161, IT35162P-RC, IT35164, IT35169P-RC, IT35170G-RC, IT35175, IT35182G-RC, IT35183P-RC, IT35186P, IT35187P, IT35189P, IT35192P, IT35193P, IT35194P, IT35195P, IT35200P, IT35201P, IT35207P, IT35208P, IT35209P, IT35211P-RC, IT35214P, IT35215P, IT35220P, IT35222P, IT35223P, IT35225P, IT35228P, IT35231P, IT35232P, IT35234P, IT35236P, IT35237P, IT35240P, IT35242P, IT35245P, IT35248P, IT35251P, IT35252P, IT35253P, IT35263P, IT35265P, IT35269P, IT35270P, IT35271P, IT35273P, IT35274P, IT35277P, IT35280P, IT35284P, IT35285P, IT35290P, IT35293P, IT35294P, IT35295P, IT35296G, IT35297P, IT35299P, IT35300P, IT35302P, IT35303P, IT35304P, IT35309G, IT35310P, IT35311P, IT35312P, IT35315P, IT35316P, IT35322P, IT35323P, IT35324P, IT35330P, IT35331P, IT35334P, IT35341G, IT35342G, IT35344, IT35348P, IT35350P, IT35351P, IT35352P, IT35360P, IT35364P-RC, IT35365P, IT35367P, IT35372P, IT35377P, IT35380P, IT35383P.
FEI Number 1720753
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information ContactDeena Pease
801-536-4516
Manufacturer Reason
for Recall		Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On October 11, 2006, GE Healthcare recalled GE OEC InstaTrak 3500 Plus System with Software version 5.2, the surgical Navigation and Visualization Application due to software related issues.
FDA Determined
Cause 2		Software design
ActionPlease be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC sent an Urgent Safety Advisory Notice dated October 11, 2006 to all affected customers. The notice identified the affected product, problem and actions to be taken. Customers were informed that a GEHC OEC would be contacting their facility to verify the current software version installed at their site. If the issue affects their facility a software upgradewill be provided at no cost. Customers were advised to excercise caution when using the affected product until the 5.2.1software upgrade is completed. For question contact GE Healthcare Customer Service at 1-800-874-7378, option 1 or 1-801-536-4688, option 1. For questions regarding this recall call 801-536-4516.
Quantity in Commerce86 units
DistributionWorldwide Distribution - US (nationwide)
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 = LLZ
-
-