Devices

Device Recall InstaTrak 3500 Plus system

Model / Serial
InstaTrak 3500 Plus systems with version 5.1 software. The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada
Product Description
InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
Manufacturer
GE OEC Medical Systems,Inc
1 Event
- Recall of Device Recall InstaTrak 3500 Plus system

Manufacturer

GE OEC Medical Systems,Inc

Manufacturer Address
GE OEC Medical Systems,Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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