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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 Recall
InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM
see related information
Date Posted December 17, 2013
Recall Status1 Open
Recall Number Z-0524-2014
Recall Event ID 66992
Premarket Notification
510(K) Number
K960330 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product InstaTrak® 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, Utah 84116-2862
For Additional Information Contact Deena 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
DESIGN: Software Design Change
Action GE 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 Commerce 654
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = VISUALIZATION TECHNOLOGY, INC.
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