Z-0135-2025 Class II Ongoing
FDA device recall Z-0135-2025 was initiated by Olympus Corporation Of The Americas on Aug 13, 2024 and is designated Class II. Reason for recall: The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or… The recall status is ongoing. Affected quantity: 159 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 30, 2024
- Initiation Date
- Aug 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 units
Product Description
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Reason for Recall
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Code Information
UDI 00821925044135 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-0135-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026