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Recall Observatory FDA recall evidence

Device product

Bodor's I series laser cutting machine.

Z-2149-2025

February 07, 2025

Class II

Product summary

Firm
Jinan Bodor Cnc Machine Co Ltd
Event
Event 97284
Status
Ongoing
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-2149-2025

Official wording

Reason: The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).

Code information: The Accession Number is 2421628- 001.

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).