Device Recall GE Cabinet Xray system 의 리콜

Recall

70478

Class 2

Z-1211-2015

2015-01-13

2015-03-20

Terminated

United States

2015-08-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133876

It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x l240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding.

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