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Recall Observatory FDA recall evidence

Device product

GE Cabinet X-ray systems

Z-0426-2015

November 10, 2014

Class II

Product summary

Firm
GE Inspection Technologies, LP
Event
Event 69846
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0426-2015

Official wording

Reason: GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.

Code information: 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.

Distribution pattern: US Distribution to the states of MI, PA, NH, CA, OR, WA, NC, IN and SC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.