FDA Enforcement
Class II
Terminated
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
Recall: Z-2236-2016
·
Reported August 3, 2016
Enforcement
- Recall Number
- Z-2236-2016
- Event ID
- 74554
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Inspection Technologies, LP
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- August 3, 2016
- Initiation Date
- March 2, 2016
- Classification Date
- July 22, 2016
- Termination Date
- August 7, 2017
- Address
- 50 Industrial Park Rd, N/A, Lewistown, PA, 17044-9312, United States
Description
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
Reason
Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
Code Info
SN - PA2384
Distribution
US Distribution to the states of : FL, TN, and TX.
Quantity
4