Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1826-2011

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

GE Inspection Technologies, LP / initiated 2009-03-16 / Terminated / root cause: labeling and UDI

GE Inspection Technologies, LP began a recall of Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1826-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Inspection Technologies, LP
Product
Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
Product code
RCE Cabinet X-Ray, Industrial
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.
Root cause tag
labeling and UDI
FDA 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 in commerce
118 units total
Distribution
Nationwide Distribution
Product codes and lots
All affected units.