FDA Recall Terminated

Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.

Recall: Z-1828-2011 · Initiated March 16, 2009

Recall

Recall Number
Z-1828-2011
Event Number
52193
FEI Number
2519904
Product Code
RCE
Status
Terminated
Root Cause
Radiation Control for Health and Safety Act
Initiated
March 16, 2009
Posted
April 6, 2011
Terminated
April 17, 2017
Address
Rd, GE Inspection Technologies, LP 50 Industrial Park, Lewistown, PA, 17044-9312

Description

Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.

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.

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.

Distribution

Nationwide Distribution

Quantity

118 units total