Beijing Syntech Laser Trixel C02 Laser Recalled for Missing Certification Label
Beijing Syntech Laser Co., Ltd is recalling 38 Trixel C02 Laser surgical lasers because the required 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 for a missing certification label, which is a documentation and labeling issue. The source text does not report any illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Beijing Syntech Laser Co., Ltd is recalling 38 units of the Trixel C02 Laser surgical laser. The recall is due to a noncompliance issue where the required certification label was not affixed on the product. The missing label should have stated: "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007."
The affected products were distributed in the US. The source text does not specify the exact distribution locations or the dates of distribution. There is no information provided regarding reported illnesses or injuries associated with this recall.
Consumers who possess this product should contact the recalling firm for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Beijing Syntech Laser Trixel C02 Laser surgical lasers
- Manufacturer
- Beijing Syntech Laser Co., Ltd
- Category
- Medical Device — Surgical Laser
- Hazard
- Affected units
- 38
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 Trixel C02 Laser
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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