FDA Device recall Z-2106-2019
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control by Comet Technologies Usa, citing 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 of the power supply….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2106-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-01 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Comet Technologies Usa |
| Distribution | US |
Product
YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Reason
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 of the power supply using only the movement of the door.
Identifiers
| code_info | X-Ray Systems |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2106-2019%22
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