[Recalled] Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers — The noncompliance is that the certification label was not affixed on the produc… | FDA 2017-07-03
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers |
|---|---|
| Brand / manufacturer | Beijing Syntech Laser Co., Ltd |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1493-2018 |
| Country of notice | China |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 July 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
This Class II recall concerns device products distributed in China and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Beijing Syntech Laser Co., Ltd
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.