Recall Z-1211-2015— 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|tome|x L240 an Cabinet X-ray system. Reason: 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..
- 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|tome|x L240 an 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 of the v|tome|x L240 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.