Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Reported: October 30, 2024 Initiated: August 13, 2024 #Z-0134-2025
Product Description
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 1373 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS. Recalled by Olympus Corporation of the Americas. Units affected: 1373 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0134-2025.
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