SOLTIVE Premium SuperPulsed Laser recall
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Why was SOLTIVE Premium SuperPulsed Laser recalled?
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.
- Product
- SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 203 Units (OUS Only)
- Distribution
- Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)