FDA Enforcement
Class II
Ongoing
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Recall: Z-2505-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2505-2024
- Event ID
- 94964
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2024
- Initiation Date
- May 31, 2024
- Classification Date
- August 5, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Reason
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Code Info
Model: TFL-SLS; UDI-DI: 00821925044135; Serial Numbers: All Serial Numbers.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Quantity
253 Units