Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are used in non-destructive testing

FDA device recall Z-1826-2011 · posted 2011-04-06 · Terminated

Recall details

Recalling firm

GE Inspection Technologies, LP

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.

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.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

RCE

Quantity affected

118 units total

Distribution

Nationwide Distribution

Date initiated

2009-03-16

Date posted

2011-04-06

Date terminated

2017-04-17

Location

Lewistown, PA