Recall Z-1225-2015 ยท RCE Cabinet X-Ray, Industrial
GE Inspection Technologies, LP
GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
| Date | Mar 20, 2015 (initiated Jan 13, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | GE Inspection Technologies, Planned Action: 1. GE will notify customers of the affected cabinet x-ray systems through a Technical Information Letter. GE notified its affected customers via email on January 13, 2015, via letter dated January 14, 2015, and via telephone on January 19, 2015. 2.GE will install an interim insert within 30 days of receipt of this letter. The insert will cover any existing or interim gaps in the original lead shielding on the door. 3. GE will replace the doors of affected cabinet x-ray systems no later than 180 day of receipt of this letter. 4. These correction |
| Quantity | 2 |
| Distribution | US Distribution to the states of OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.