FDA Device recall Z-1494-2018
Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
- FDA Device
- Class II
- ongoing
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Beijing Syntech Laser Nice Station Light Based Platform surgical lasers by Beijing Syntech Laser, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1494-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-07-03 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beijing Syntech Laser |
| Distribution | n/a |
Product
Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
Reason
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".
Identifiers
| code_info | Model Nice Station Light Based Platform |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1494-2018%22
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