ENTrak Plus Navigation and Visualization System
This recall has been terminated (originally issued May 11, 2005).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- July 12, 2004
- Posted
- May 11, 2005
- Terminated
- August 2, 2011
- Recall Number
- Z-0813-05
- Quantity
- 2 kits
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
Distribution
Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.
Lot / Code Info
Axcess System Kit P/N: 1005869-001
Root Cause
Other
Action Taken
Customers were notified by letter on 07/12/04.
More recalls by Ge Oec Medical Systems, Inc
OEC 3D REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopi...
Dec 18, 2024
OEC 9800 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed...
Dec 18, 2024
OEC 9900 REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoro...
Dec 18, 2024
OEC Elite REF
Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is i...
Dec 18, 2024
OEC 9800 Systems with 9-inch Image Intensifier
Jul 31, 2023