FDA-Device2012-08-29Class II
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open 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, MRI, or X-ray.
GE OEC Medical Systems, Inc
Hazard
GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
Sold states
Nationwide Distribution.
Affected count
99 units
Manufactured in
384 Wright Brothers Dr, N/A, Salt Lake City, UT, United States
Products
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open 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, MRI, or X-ray.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2236-2012Don't want to check this manually?
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