Z-2236-2016 Class II Terminated
FDA device recall Z-2236-2016 was initiated by GE Inspection Technologies, LP on March 2, 2016 and is designated Class II. Reason for recall: 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. Jo… The recall status is terminated (terminated August 7, 2017). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2016
- Initiation Date
- March 2, 2016
- Termination Date
- August 7, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 4
Product 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 for Recall
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.
Distribution Pattern
US Distribution to the states of : FL, TN, and TX.
Code Information
SN - PA2384