The Recall Desk
ModerateFDA (Devices)·Z-1493-2018·Announced 2018-05-09

Beijing Syntech Laser APOLLO JV+ Medical Platform Recalled for Missing Label

Beijing Syntech Laser is recalling six APOLLO JV+ Medical Platform surgical lasers because the required certification label was not affixed to the products.

What this means for you

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 and involves a labeling error (missing certification label) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Beijing Syntech Laser Co., Ltd is recalling six units of the APOLLO JV+ Medical Platform surgical lasers. The recall was initiated because the products did not have the required certification label affixed to them.

The missing label was 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. The agency classified this recall as Class II.

The affected units were distributed in the US. Consumers and healthcare providers who possess these specific surgical lasers should contact the recalling firm for instructions on how to proceed.

The recalled product

Product
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Affected units
6

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 1V+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 →