Recall Z-1827-2011
GE Inspection Technologies, LP · initiated March 16, 2009
Product
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.
Codes / lots: All affected units.
Reason for recall
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.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
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.
Details
- Recall number
- Z-1827-2011
- Initiated
- March 16, 2009
- Posted by FDA
- April 6, 2011
- Terminated
- April 17, 2017
- Product code
- RCE – Cabinet X-Ray, Industrial
- Quantity
- 118 units total
- Distribution
- Nationwide Distribution
- Recalling firm
- GE Inspection Technologies, LP, Lewistown, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1825-2011 | Phoenix x/ray analyser series. Phoenix x|ray analyser series cabinet x-ray systems are…Some of the systems do not have a safety interlock on the service access panel. Although the systems have… | 03/16/2009Terminated |
| Z-1826-2011 | Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are…Some of the systems do not have a safety interlock on the service access panel. Although the systems have… | 03/16/2009Terminated |
| Z-1828-2011 | Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are…Some of the systems do not have a safety interlock on the service access panel. Although the systems have… | 03/16/2009Terminated |