FDA Enforcement
Class II
Terminated
GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
Recall: Z-1211-2015
·
Reported April 1, 2015
Enforcement
- Recall Number
- Z-1211-2015
- Event ID
- 70478
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Inspection Technologies, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2015
- Initiation Date
- January 13, 2015
- Classification Date
- March 20, 2015
- Termination Date
- August 17, 2015
- Address
- 50 Industrial Park Rd, Lewistown, PA, 17044-9312, United States
Description
GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
Reason
It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x L240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
Code Info
SN - PA1260
Distribution
US Distribution to the states of OH and PA.
Quantity
2