Z-2236-2016Class II

GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used...

Name: Z-2236-2016 GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used...
Creator: GE Inspection Technologies, LP
Published: 2016-03-02
License: https://open.fda.gov/license/

GE Inspection Technologies, LP / initiated 2016-03-02 / Terminated

FDA source

GE Inspection Technologies, LP began a recall of GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis on 2016-03-02. FDA classified it as Class II and gives the reason as "Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2236-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-02
Posted: 2016-07-23
Terminated: 2017-08-07
Recalling firm: GE Inspection Technologies, LP
Product: GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis.
Product code: RCE Cabinet X-Ray, Industrial
Reason for recall: Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan.
Quantity in commerce: 4
Distribution: US Distribution to the states of : FL, TN, and TX.
Product codes and lots: SN - PA2384

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2236-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2236-2016	Class II	Terminated	FDA Mandated	2016-08-03	2016-07-22

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)