Recall Z-2236-2016 ยท RCE Cabinet X-Ray, Industrial
GE Inspection Technologies, LP
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
| Date | Jul 23, 2016 (initiated Mar 2, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan. |
| Quantity | 4 |
| Distribution | US Distribution to the states of : FL, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.