Bodor i Series laser cutting machines fail federal laser safety standards
Bodor i Series laser cutting machines are being recalled because they fail to meet certain applicable federal standards at 21 CFR 1040.10(f)(1) and (f)(2). 20 units are affected.
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: Risk-of-harm product: laser performance requirements in the federal safety standard are not met, with no injury reported in the source.
Plain-English summary
Bodor's i Series laser cutting machine is being recalled under accession number 2421628-001. The action covers 20 units.
The stated reason is that the Bodor i Series products fail to meet certain applicable Federal standards, specifically 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2). The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was in the United States.
Operators should identify affected machines by accession number and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Bodor's I series laser cutting machine.
- Manufacturer
- Jinan Bodor Cnc Machine Co Ltd
- Category
- Other — Laser cutting machine
- Affected units
- 20
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)
- The Accession Number is 2421628- 001.
Distribution
Distribution scope not specified by the agency.
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