Z-0426-2015Class II

GE Cabinet X-ray systems

Name: Z-0426-2015 GE Cabinet X-ray systems
Creator: GE Inspection Technologies, LP
Published: 2014-11-10
License: https://open.fda.gov/license/

GE Inspection Technologies, LP / initiated 2014-11-10 / Terminated

FDA source

GE Inspection Technologies, LP began a recall of GE Cabinet X-ray systems on 2014-11-10. FDA classified it as Class II and gives the reason as "GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0426-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-10
Posted: 2014-12-17
Terminated: 2015-06-29
Recalling firm: GE Inspection Technologies, LP
Product: GE Cabinet X-ray systems
Product code: RCE Cabinet X-Ray, Industrial
Reason for recall: GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE intends to notify its customers of the affected cabinet x-ray systems regarding the warning signs' potential failure to comply with 21 C.F.R. 1020.40(c)(7)(v) through a Technical Information Letter. The notification will inform customers that GE plans to replace the current warning signs with warning signs that comply with the requirements set forth in 21 C.F.R. 1020.40(c)(7)(v). GE will recommend in its notification that it replace the warning sign at the customer's next service interval, but no later than December 31, 2014. For further questions please call (717) 447-1278.
Quantity in commerce: 11
Distribution: US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.
Product codes and lots: XXL cabinet x-ray systems, serial numbers A586590 and A586780; xlcube compact cabinet x-ray systems, serial numbers A583730, A586430, and A586460; a VTOMEX C450 cabinet x-ray system, serial number VTXO1JOOO2-2245 14; VTOMEX L300 cabinet x-ray systems, serial numbers VTX01lF007-208813, VTX01F007-196312 and VTXO1FOO07-1946 12; and VTOMEX L450 cabinet x-ray systems, serial numbers VTXO1K0001-184711 and PX_10E000-179013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0426-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0426-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

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)