Z-2504-2024 Class II Ongoing
FDA device recall Z-2504-2024 was initiated by Olympus Corporation Of The Americas on May 31, 2024 and is designated Class II. Reason for recall: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure. The recall status is ongoing. Affected quantity: 1,585 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 14, 2024
- Initiation Date
- May 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,585 Units
Product Description
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Reason for Recall
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Code Information
Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2504-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026