FDA Enforcement
Class II
Terminated
OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
Recall: Z-0193-2015
·
Reported November 19, 2014
Enforcement
- Recall Number
- Z-0193-2015
- Event ID
- 69474
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE OEC Medical Systems, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 19, 2014
- Initiation Date
- October 3, 2014
- Classification Date
- November 7, 2014
- Termination Date
- March 23, 2015
- Address
- 384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862, United States
Description
OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
Reason
GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
Code Info
Serial No: 86-0039,86-0135,86-0191,86-0318,86-0334,86-0587,86-0611,86-0619,86-0758,86-0782,86-0931,86-0935-RC,86-1129,86-1220,86-1241,86-1376,86-1432,86-1503,86-1551,86-1614,86-1678,86-1702,86-1736,86-1959,86-2092,86-2119
Distribution
Worldwide Distribution.
Quantity
26