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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83295

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 01, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Comet Technologies Usa Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

Z-2105-2019
Recall number
Z-2105-2019
Initiated
October 01, 2018
Classification
Class II
Status
Terminated
Quantity
77

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

X-Ray Systems

Distribution pattern

US Nationwide Distribution

device · product 2 of 2

YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control

Z-2106-2019
Recall number
Z-2106-2019
Initiated
October 01, 2018
Classification
Class II
Status
Terminated
Quantity
93

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

X-Ray Systems

Distribution pattern

US Nationwide Distribution