IDS LTD: Device Recall
Recall #Z-0804-2025 · 10/16/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0804-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- IDS LTD
- Status
- Ongoing
- Date Initiated
- 10/16/2024
- Location
- Paju, Korea (the Republic of)
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 23
Reason for Recall
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Product Description
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Distribution Pattern
Worldwide - US Nationwide Distribution
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.