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U.S. Department of Health and Human Services

Class 2 Device Recall InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM

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 Class 2 Device Recall InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTMsee related information
Date Initiated by FirmNovember 26, 2013
Date PostedDecember 17, 2013
Recall Status1 Terminated 3 on April 17, 2017
Recall NumberZ-0524-2014
Recall Event ID 66992
510(K)NumberK960330 
Product Classification System, image processing, radiological - Product Code LLZ
ProductInstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Code Information Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information ContactDeena Pease
801-536-4952
Manufacturer Reason
for Recall		GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
FDA Determined
Cause 2		Software Design Change
ActionGE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952.
Quantity in Commerce654
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 = LLZ
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