Z-1225-2015 Class II Terminated
FDA device recall Z-1225-2015 was initiated by GE Inspection Technologies, LP on January 13, 2015 and is designated Class II. Reason for recall: It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding. The recall status is terminated (terminated August 17, 2015). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2015
- Initiation Date
- January 13, 2015
- Termination Date
- August 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
Reason for Recall
It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
Distribution Pattern
US Distribution to the states of OH and PA.
Code Information
SN - PA1053