Z-1385-2024 Class II Ongoing
FDA device recall Z-1385-2024 was initiated by Olympus Corporation Of The Americas on Jan 29, 2024 and is designated Class II. Reason for recall: A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations. The recall status is ongoing. Affected quantity: 203 Units (OUS Only).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Jan 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 203 Units (OUS Only)
Product Description
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Reason for Recall
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Distribution Pattern
Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Code Information
Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1385-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026