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Recall Observatory FDA recall evidence

Device product

GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.

Z-1225-2015

January 13, 2015

Class II

Product summary

Firm
GE Inspection Technologies, LP
Event
Event 70478
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1225-2015

Official wording

Reason: It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.

Code information: SN - PA1053

Distribution pattern: US Distribution to the states of OH and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.