FDAFDA · Food and drugs·Recall number Z-2504-2024
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Published August 14, 2024 · Recall initiated: May 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
- Lot
- Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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