Drug recall
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
FDA recall event 79697 · Class II · Beijing Syntech Laser Co., Ltd
Key facts
| Event ID | 79697 |
|---|---|
| Recall numbers | Z-1488-2018, Z-1489-2018, Z-1490-2018, Z-1491-2018, Z-1492-2018, Z-1493-2018, Z-1494-2018, Z-1495-2018 |
| Recalling firm | Beijing Syntech Laser Co., Ltd |
| Product type | Devices |
| Products | Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers, Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers, Beijing Syntech Laser Diode Laser surgical lasers, Beijing Syntech Laser Nice Station Light Based Platform surgical lasers, Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers and 3 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA Requested |
| Reason for recall | 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… |
| Initiation date | Jul 3, 2017 |
| Report date | May 9, 2018 |
| City | Beijing |
| Country | China |
| FEI number | 3007535734 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: