Reported Aug 29, 2012 · Terminated
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures…
GE OEC Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE OEC Medical Systems, Inc · 384 Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- 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.
- Lot codes and dates
- Model number A857680 with various serial numbers (refer to consignee list).
- Amount recalled
- 99 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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