Recall Z-1827-2011 ยท RCE Cabinet X-Ray, Industrial
GE Inspection Technologies, LP
Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
| Date | Apr 6, 2011 (initiated Mar 16, 2009) |
| Status | Terminated |
| Reason | Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed. Two of the systems also lack the sign indicating the meaning of the warning signals. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The firm has completed all of the following necessary actions and no further actions have been indicated: A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062. |
| Quantity | 118 units total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.