# FDA recall Z-1488-2018

> **Beijing Syntech Laser Co., Ltd** · Class II · device recall initiated 2017-07-03.

## Product

Beijing Syntech Laser Diode Laser    surgical lasers

## 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 June 24, 2007".

## Distribution

US Distribution

## Key facts

- **Recall number:** Z-1488-2018
- **Recalling firm:** Beijing Syntech Laser Co., Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-07-03
- **Report date:** 2018-05-09

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Beijing, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2018

## Citation

> AI Analytics. FDA recall Z-1488-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1488-2018. Source: US FDA. Licensed CC0.

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