FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: Radiological Image Processing System The system is an aid to locate anatomical structures during open or 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 CS, MR, or X-ray.
- Recall number
- Z-2136-2012
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- Radiological Image Processing System The system is an aid to locate anatomical structures during open or 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 CS, MR, or X-ray.
- Status
- Terminated
- Initiated
- 2007-04-02
- Posted
- 2012-08-08
- Terminated
- 2012-09-28
- Reason
- The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image.
- Root cause
- Software design
- Action
- GE Healthcare sent an Urgent Recall Notice dated April 2, 2007, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were asked to call 800-874-7378. For questions regarding this recall call 801-536-4952,
- Quantity
- 17
- Distribution
- Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China
- Lot, serial or model codes
- E9-0002-G, ES-0013-G, E9-0036-G, E9-0040-G, E9-0041-G, ES-0014-G, ES-0016-G, ES-0033-G, ES-0043-G, ES-0041-G, ES-0042-G, ES-OO84-G, ES-0086-G, ES-0163-G, E9-0089-G, ES-0026-G, ES-0044-G
- 510(k) numbers
- ["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