Beijing Syntech Laser APOLLO JV+ Medical Platform Surgical Lasers Recall
Beijing Syntech Laser recalls APOLLO JV+ Medical Platform surgical lasers due to missing certification labels. This noncompliance may affect product safety compliance with U.S. regulations.
Lower-risk 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 June 24, 2007".
Contact the company
What happened, in plain English
Beijing Syntech Laser is recalling its APOLLO JV+ Medical Platform surgical lasers because the product lacks a required certification label. This issue could mean the device doesn't meet U.S. regulatory standards, potentially affecting safety. Read more at govinfonow.com/recall/73471-beijing-syntech-laser-apollo-jv-medical-platform-surgical-lasers-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/73471-beijing-syntech-laser-apollo-jv-medical-platform-surgical-lasers-recall · Updated September 21, 2026 · FDA enforcement record: FDA #Z-1493-2018
Cite this page
“Beijing Syntech Laser APOLLO JV+ Medical Platform Surgical Lasers Recall.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73471-beijing-syntech-laser-apollo-jv-medical-platform-surgical-lasers-recall. Based on FDA recall #Z-1493-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1493-2018%22&limit=1).
Why it’s dangerous
The device lacks a required certification label that confirms it meets U.S. regulatory standards. This noncompliance means the product may not be safe for use as intended, though the specific risk is not described as causing injury.
Who’s affected
Medical professionals who own or use the APOLLO JV+ Medical Platform surgical lasers are likely affected. Patients and staff at facilities using these lasers may be at risk if the device is not properly certified.
How to tell if you have this one
Check for the product name 'Beijing Syntech Laser APOLLO JV+ Medical Platform' and model 'APOLLO 1V+Medical Platform'. The recall applies to devices sold in the U.S. without the required certification label.
- Brand
Beijing Syntech Laser- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1488-2018 | Beijing Syntech Laser Diode Laser surgical lasers; Model Diode Laser | 13 |
| Z-1489-2018 | Beijing Syntech Laser Trixel C02 Laser surgical lasers; Model Trixel C02 Laser | 38 |
| Z-1490-2018 | Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers; Model Trixel 11 C02 Laser | 3 |
| Z-1491-2018 | Beijing Syntech Laser UL C02 Laser surgical lasers; Model UL C02 Laser | 92 |
| Z-1492-2018 | Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers; Model Apollo V + Medical Platform | 11 |
| Z-1493-2018 | Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers; Model APOLLO 1V+Medical Platform | 6 |
| Z-1494-2018 | Beijing Syntech Laser Nice Station Light Based Platform surgical lasers; Model Nice Station Light Based Platform | 7 |
| Z-1495-2018 | Beijing Syntech Laser UL Station surgical lasers; Model UL Station | 199 |
What to do — step by step
Check Certification Label
Look for the required certification label that states compliance with 21 CFR 1040.10 and 1040.11, except for deviations per Laser Notice No. 50.
How this recall unfolded
Recall timeline
FDA published this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1493-2018 (July 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1493-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.