Home › Device types › RCE
Cabinet X-Ray, Industrial
FDA product code RCE · Class N · Unknown
0
Registered devices
9
Adverse events
21
Recalls
0
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-24 | Spectral Instruments Inc | Momentary absence of On-Screen "X-Ray On" banner during run readiness check. |
| 2026-07-24 | Spectral Instruments Inc | Momentary absence of On-Screen "X-Ray On" banner during run readiness check. |
| 2025-05-13 | Spectral Instruments Inc | The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH. |
| 2025-05-13 | Spectral Instruments Inc | The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH. |
| 2020-09-29 | Ge Inspection Technologies Llc | 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 wit |
| 2019-12-23 | Nikon Metrology | The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions [21 CFR |
| 2018-10-01 | Comet Technologies Usa Inc | Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection o |
| 2018-10-01 | Comet Technologies Usa Inc | Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection o |
| 2017-11-14 | Carl Zeiss Metrology Inc | Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user ini |
| 2017-08-23 | North Star Imaging Inc | It was discovered a low-level radiation leak that was found on the NSI X-7000 system. |
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