Recall Z-1225-2015— GE Inspection Technologies, LP
Class II · Terminated
Class II FDA medical device recall by GE Inspection Technologies, LP, initiated 2015-01-13, terminated 2015-08-17. FDA's recall record names no specific 510(k) clearance for this event. Product: GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.. 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..
- Recalling firm
- GE Inspection Technologies, LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-13
- Terminated
- 2015-08-17
- Firm location
- Lewistown, PA, United States
Product description
GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.