Z-2106-2019Class II

YXLON Cougar Cabinet X-Ray System

Name: Z-2106-2019 YXLON Cougar Cabinet X-Ray System
Creator: Comet Technologies Usa Inc
Published: 2018-10-01
License: https://open.fda.gov/license/

Comet Technologies USA Inc / initiated 2018-10-01 / Terminated

FDA source

Comet Technologies Usa Inc began a recall of YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control on 2018-10-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2106-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-01
Posted: 2019-08-07
Terminated: 2024-06-13
Recalling firm: Comet Technologies USA Inc
Product: YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Product code: RCE Cabinet X-Ray, Industrial
Reason for recall: 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.
FDA root cause: Radiation Control for Health and Safety Act
Action: The firm sent a notification letter dated July 2019, to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were informed that a service technician will be contacting you to schedule the retrofit service. For questions, call YXLON Service at (234) 284-7881.
Quantity in commerce: 93
Distribution: US Nationwide Distribution
Product codes and lots: X-Ray Systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2106-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2105-2019	Class II	Terminated	FDA Mandated	2019-08-14	2019-08-07
Z-2106-2019	Class II	Terminated	FDA Mandated	2019-08-14	2019-08-07

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)