Material processing lasers recalled for lacking a required remote interlock connector
Shenzhen Atomstack Technologies is recalling material processing laser products for lacking a remote interlock connector required under 21 CFR 1040.10(f)(3).
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: Scored 3 under the risk-of-harm criterion: the products lack a safety feature required by the federal laser performance standard, and no injuries are reported.
Plain-English summary
Material Processing Laser Products from Shenzhen Atomstack Technologies are being recalled.
The reason given in the enforcement record is a lack of a remote interlock connector, which is required per 21 CFR 1040.10(f)(3).
The record does not state a quantity or product codes. Distribution was in the United States. The FDA has classified the action as Class II.
A remote interlock connector is a safety feature required by the federal laser product performance standard. The enforcement record reports no injuries. Owners should follow the firm's instructions.
The recalled product
- Product
- Material Processing Laser Products
- Manufacturer
- SHENZHEN ATOMSTACK TECHNOLOGIES
- Category
- Other — Laser product
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)
- N/A
Distribution
Distribution scope not specified by the agency.
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