Device product
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
Z-2506-2024
Product summary
- Event
- Event 94964
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,838 Units
- Official record key
device-enforcement:Z-2506-2024
Official wording
Reason: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Code information: Model: TFL-AFSWL; UDI-DI: 00821925044258; Serial Numbers: All Serial Numbers.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Derived failure modes
-
Unknown
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.