Recall Z-2777-2017 ยท RCE Cabinet X-Ray, Industrial
GE Inspection Technologies, LP
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
| Date | Jun 28, 2017 |
| Status | Terminated |
| Reason | GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Inspection Technologies will bring the defect into compliance: 1. Four panels of sheet metal/lead/sheet metal construction (6 mm lead thickness) will be permanently mounted using an industrial epoxy to the inside floor of the cabinet to prevent emissions from exceeding the limit in the performance standard. A radiation emission measurement will be made following the repairs of each system to assure the issue was corrected. 2. GE will notify affected customers within 5 days of GEs receipt of this approval letter. 3. The notification will recommend that customers allow GE to visit |
| Quantity | 13 units distributed in the US |
| Distribution | US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.