Beijing Syntech Laser APOLLO V+ Medical Platform Recalled for Missing Label
Beijing Syntech Laser Co., Ltd is recalling 11 APOLLO V+ Medical Platform 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, injuries, or deaths, and the hazard is theoretical rather than a direct physical defect causing harm.
Plain-English summary
Beijing Syntech Laser Co., Ltd is recalling 11 units of the APOLLO V+ Medical Platform surgical lasers. The recall was initiated because the required certification label was not affixed to the product. The missing label is required to state that the device complies with 21 CFR 1040.10 and 1040.11, except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.
The affected units were distributed in the US. The source text does not specify the exact distribution locations or the dates of distribution. The recall is classified as Class II by the FDA.
Consumers and healthcare facilities should stop using the affected devices and contact the recalling firm for instructions on how to proceed. The source text does not provide specific contact information or a return address.
The recalled product
- Product
- Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
- Manufacturer
- Beijing Syntech Laser Co., Ltd
- Category
- Medical Device — Surgical Lasers
- Hazard
- Affected units
- 11
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 Apollo V + Medical 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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