CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
Yxlon Cheetah cabinet X-Ray System recalled by Comet Technologies Usa
Comet Technologies Usa is recalling Yxlon Cheetah cabinet X-Ray System, distributed nationwide in the US. The recall was initiated on 1 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2105-2019
- FDA event ID
- 83295
- Recalling firm
- Comet Technologies Usa, Shelton, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2018
- FDA classified
- 7 Aug 2019
- Reported
- 14 Aug 2019
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 1 Oct 2018 | Recall initiated by company | |
| 7 Aug 2019 | Classified by FDA | +310 days |
| 14 Aug 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Yxlon Cheetah cabinet X-Ray System recalled?
Yes. Comet Technologies Usa recalled Yxlon Cheetah cabinet X-Ray System on 1 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-2105-2019.
Why was it recalled?
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.
Which lots are affected?
X-Ray Systems
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Comet Technologies Usa
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Yxlon Cougar Cabinet X-Ray System recalled by Comet Technologies Usa | Comet Technologies Usa | Device Malfunction | Nationwide |
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