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Recall Observatory FDA recall evidence

Device 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.

Z-2236-2016

March 02, 2016

Class II

Product summary

Firm
GE Inspection Technologies, LP
Event
Event 74554
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-2236-2016

Official wording

Reason: 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.

Code information: SN - PA2384

Distribution pattern: US Distribution to the states of : FL, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.