OEC InstaTrak 3500 — Class II medical device recall Z-2236-2012
Terminated recall by GE OEC Medical Systems, Inc, reported 2012-08-29, distributed nationwide. GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when
| Recall number | Z-2236-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2006-10-11 |
| Classified | 2012-08-21 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2012-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 99 units |
| Model numbers | A857680 |
Product
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.