Soltive Premium SuperPulsed Laser System recall
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Why was Soltive Premium SuperPulsed Laser System recalled?
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
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: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.
- Product
- Soltive Premium SuperPulsed Laser System, Model TFL-PLS
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1,585 Units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
- Recall date
- August 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)