Comet Technologies Recalls YXLON Cougar Cabinet X-Ray Systems
Comet Technologies is recalling 93 YXLON Cougar Cabinet X-Ray Systems because the door interlocks fail to meet federal performance standards for power disconnection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a failure of a safety interlock in an x-ray system, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Comet Technologies USA Inc is recalling 93 YXLON Cougar Cabinet X-Ray Systems. These products are generally used for non-destructive testing and quality control. The recall covers units distributed nationwide in the United States.
The recall was issued because the products fail to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40). Specifically, the door interlock that causes physical disconnection of the power supply using only the movement of the door does not function as required.
The source text does not specify a date for the recall or provide instructions for consumers on how to resolve the issue. Users of these systems should contact the manufacturer for further information.
The recalled product
- Product
- YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
- Manufacturer
- Comet Technologies Usa Inc
- Category
- Medical Device — X-Ray Systems
- Hazard
- Affected units
- 93
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- X-Ray Systems
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Comet Technologies Usa Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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