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

FDA device recall Z-1225-2015 · posted 2015-03-20 · Terminated

Recall details

Recalling firm

GE Inspection Technologies, LP

Reason for recall

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.

Action taken

GE Inspection Technologies, Planned Action: 1. GE will notify customers of the affected cabinet x-ray systems through a Technical Information Letter. GE notified its affected customers via email on January 13, 2015, via letter dated January 14, 2015, and via telephone on January 19, 2015. 2.GE will install an interim insert within 30 days of receipt of this letter. The insert will cover any existing or interim gaps in the original lead shielding on the door. 3. GE will replace the doors of affected cabinet x-ray systems no later than 180 day of receipt of this letter. 4. These corrections will be made free of charge. The Technical Information Letter used for notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter For further questions, please call (717) 447-1278

Root cause

Device Design

Status

Terminated

Product code

RCE

Quantity affected

2

Distribution

US Distribution to the states of OH and PA.

Date initiated

2015-01-13

Date posted

2015-03-20

Date terminated

2015-08-17

Location

Lewistown, PA