EPA (Environmental Protection Agency)
1 records
fda
7 records
FDA Device Recall: v|tome|x L Series non-destructive testing cabinet x-ray systems
2020-11-25
Class II — It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm...
View Source
FDA Device Recall: GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
2017-08-09
Class II — GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one h...
View Source
FDA Device Recall: GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality
2016-04-13
Class II — GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X¿ ray System perf...
View Source
FDA Recall: GE Inspection Technologies, LP — Class II
20150819
GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device. | Product: GE Optional Laser Centering Device X-ray generator...
View Source
FDA Device Recall: GE Optional Laser Centering Device X-ray generator.
2015-08-19
Class II — GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
View Source
FDA Device Recall: GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
2015-04-01
Class II — 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...
View Source
FDA Device Recall: GE Cabinet X-ray systems
2014-12-24
Class II — GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards.
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.