Recall Z-2136-2012— GE OEC Medical Systems, Inc
Class I · Terminated
Class I FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2007-04-02, terminated 2012-09-28. It names one FDA 510(k) clearance: K994270. 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.. 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..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2007-04-02
- Terminated
- 2012-09-28
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.