OEC IT3000 — Class I medical device recall Z-2251-2012
Terminated recall by GE OEC Medical Systems, Inc, reported 2012-09-05, distributed nationwide. GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuratio
| Recall number | Z-2251-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE OEC Medical Systems, Inc, Salt Lake City, UT, United States |
| Recall initiated | 2009-06-22 |
| Classified | 2012-08-28 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2012-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, DE, DK, FR, GB, HK, IN, IT, JP |
| Quantity | 768 units |
| Serial numbers | IT2500, IT3000 |
Product
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended 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 Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.
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.