Beijing Syntech Laser Trixel 11 CO2 Laser Recalled for Missing Label
Beijing Syntech Laser Co., Ltd is recalling three Trixel 11 CO2 surgical lasers because the required certification label was not affixed to the products.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling issue (missing certification label) with no reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Beijing Syntech Laser Co., Ltd is recalling three units of the Trixel 11 CO2 surgical laser. The recall was initiated because the products did not have the required certification label affixed to them.
The missing label was required to state: "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007." This label is necessary to indicate compliance with specific federal laser product safety standards.
The affected units were distributed in the United States. Consumers and healthcare facilities should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
- Manufacturer
- Beijing Syntech Laser Co., Ltd
- Category
- Medical Device — Surgical Laser
- Hazard
- Affected units
- 3
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 11 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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