Cabinet X-Ray, Industrial
FDA product code RCE · Not classified
A cabinet x-ray system used for quality control, non-destructive testing, or some other industrial purpose.
0510(k) clearances
0PMA approvals
21recalls
GMP exemptexempt from GMP rules
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2940-2026 Class II | Ami HTXMomentary absence of On-Screen "X-Ray On" banner during run readiness check. | Spectral Instruments Inc | 07/24/2026Open, Classified |
| Z-2939-2026 Class II | Lago XMomentary absence of On-Screen "X-Ray On" banner during run readiness check. | Spectral Instruments Inc | 07/24/2026Open, Classified |
| Z-1942-2025 Class II | Ami HTX.The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond… | Spectral Instruments Inc | 05/13/2025Open, Classified |
| Z-1941-2025 Class II | Lago XThe X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond… | Spectral Instruments Inc | 05/13/2025Open, Classified |
| Z-0442-2021 Class II | v|tome|x L Series non-destructive testing cabinet x-ray systemsIt was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does… | Ge Inspection Technologies Llc | 09/29/2020Terminated |
| Z-1727-2020 Class II | Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST…The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system… | Nikon Metrology | 12/23/2019Terminated |
| Z-2106-2019 Class II | YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for…Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a… | Comet Technologies Usa Inc | 10/01/2018Terminated |
| Z-2105-2019 Class II | YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for…Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a… | Comet Technologies Usa Inc | 10/01/2018Terminated |
| Z-0379-2018 Class II | Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting…Due to a software error, it was observed that when the user closes the access door, the system will resume… | Carl Zeiss Metrology Inc | 11/14/2017Open, Classified |
| Z-0063-2018 Class II | North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial…It was discovered a low-level radiation leak that was found on the NSI X-7000 system. | North Star Imaging Inc | 08/23/2017Open, Classified |
| Z-2777-2017 Class II | GE Inspection Technologies Blade|line Industrial Cabinet X-ray systemGE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the… | GE Inspection Technologies, LP | 06/28/2017Terminated |
| Z-2236-2016 Class II | GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A…Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of… | GE Inspection Technologies, LP | 03/02/2016Terminated |
| Z-1231-2016 Class II | GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully… | GE Inspection Technologies, LP | 12/16/2015Terminated |
| Z-2376-2015 Class II | PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer…Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled… | BIOTRONIK, Inc. | 06/30/2015Terminated |
| Z-1225-2015 Class II | GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed… | GE Inspection Technologies, LP | 01/13/2015Terminated |
| Z-1211-2015 Class II | GE Inspection Technologies x|tome|x L240 an Cabinet X-ray systemIt was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the… | GE Inspection Technologies, LP | 01/13/2015Terminated |
| Z-0426-2015 Class II | GE Cabinet X-ray systemsGE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System… | GE Inspection Technologies, LP | 11/10/2014Terminated |
| Z-0833-2012 | GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory…Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR… | GE Healthcare, LLC | 01/31/2011Terminated |
| Z-1828-2011 | Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are…Some of the systems do not have a safety interlock on the service access panel. Although the systems have… | GE Inspection Technologies, LP | 03/16/2009Terminated |
| Z-1827-2011 | Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are…Some of the systems do not have a safety interlock on the service access panel. Although the systems have… | GE Inspection Technologies, LP | 03/16/2009Terminated |
| Z-1826-2011 | Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are…Some of the systems do not have a safety interlock on the service access panel. Although the systems have… | GE Inspection Technologies, LP | 03/16/2009Terminated |
| Z-1825-2011 | Phoenix x/ray analyser series. Phoenix x|ray analyser series cabinet x-ray systems are…Some of the systems do not have a safety interlock on the service access panel. Although the systems have… | GE Inspection Technologies, LP | 03/16/2009Terminated |