Z-0804-2025 Class II Ongoing
FDA device recall Z-0804-2025 was initiated by IDS LTD on October 16, 2024 and is designated Class II. Reason for recall: The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. The recall status is ongoing. Affected quantity: 23.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- October 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 23
Product Description
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Reason for Recall
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Distribution Pattern
Worldwide - US Nationwide Distribution
Code Information
unknown