Z-1828-2011

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

Name: Z-1828-2011 Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive...
Creator: GE Inspection Technologies, LP
Published: 2009-03-16
License: https://open.fda.gov/license/

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

FDA source

GE Inspection Technologies, LP began a recall of 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... on 2009-03-16. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1828-2011
Status: Terminated
Initiated: 2009-03-16
Posted: 2011-04-06
Terminated: 2017-04-17
Recalling firm: GE Inspection Technologies, LP
Product: 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.
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.

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)