Beijing Syntech Laser surgical lasers recalled for missing certification label
Beijing Syntech Laser Co., Ltd is recalling seven Nice Station Light Based Platform surgical lasers because the required laser safety certification label was not affixed to the product.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a labeling error (missing certification label) rather than a functional defect or reported injury, which aligns with the 'Moderate' severity criteria for minor labeling errors.
Plain-English summary
Beijing Syntech Laser Co., Ltd is recalling seven units of the Nice Station Light Based Platform surgical lasers. The recall was initiated because the products did not have the required certification label affixed to them.
The missing label is required to state that the product complies with 21 CFR 1040.10 and 1040.11, except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007. This noncompliance means the devices lack the specific regulatory documentation required for laser safety.
The recall affects seven units distributed in the US. Consumers and healthcare facilities should stop using these devices and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
- Manufacturer
- Beijing Syntech Laser Co., Ltd
- Category
- Medical Device — Surgical Lasers
- Hazard
- Affected units
- 7
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)
- Model Nice Station Light Based Platform
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 recalled by Beijing Syntech Laser Co., Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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