FDA Enforcement
Class II
Terminated
GE Cabinet X-ray systems
Recall: Z-0426-2015
·
Reported December 24, 2014
Enforcement
- Recall Number
- Z-0426-2015
- Event ID
- 69846
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Inspection Technologies, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2014
- Initiation Date
- November 10, 2014
- Classification Date
- December 17, 2014
- Termination Date
- June 29, 2015
- Address
- 50 Industrial Park Rd, N/A, Lewistown, PA, 17044-9312, United States
Description
GE Cabinet X-ray systems
Reason
GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
Code Info
XXL cabinet x-ray systems, serial numbers A586590 and A586780; xlcube compact cabinet x-ray systems, serial numbers A583730, A586430, and A586460; a VTOMEX C450 cabinet x-ray system, serial number VTXO1JOOO2-2245 14; VTOMEX L300 cabinet x-ray systems, serial numbers VTX01lF007-208813, VTX01F007-196312 and VTXO1FOO07-1946 12; and VTOMEX L450 cabinet x-ray systems, serial numbers VTXO1K0001-184711 and PX_10E000-179013.
Distribution
US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
Quantity
11