FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: 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.
- Recall number
- Z-2251-2012
- Recalling firm
- GE OEC Medical Systems, Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-06-22
- Posted
- 2012-08-28
- Terminated
- 2012-09-28
- Reason
- 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.
- Root cause
- Labeling False and Misleading
- Action
- GE Healthcare sent an Urgent Safety Advisory Notice dated June 22, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised not to use the ENT registration Headset in the inverted position for any CT scans or surgical procedures and to remove all references in their Naviation System Operator's Manual that discuss an inverted headset placement, and replace it with the enclosed updated instructions for the Navigation System Operator's Manual. For any questions customers should contact the service team for further information at 800-874-7378, option #8. For questions regarding this recall call 801-536-4516.
- Quantity
- 768 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of India, Japan, Canada, Switzerland, Italy, United Kingdom, Germany, Austria, Hong Kong, France, and Denmark.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K960330","K981998","K982994","K983529","K990919","K994270"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28