SOLTIVE recallZ-0134-2025 · Olympus Corporation of the Americas · initiated Aug 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Olympus issued Urgent Medical Device Correction Letter on 9/12/24 to Operating Room Director, Risk Management. Letter states reason foe recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Please check all areas of your facility to determine if you have the devices specified above. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use. 4. If you have further distributed this product, identify your customers, and forward them this notification. 5. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0452 c. Complete the form as instructed. If you require additional information, please do not hesitate to contact me at [email protected] or by phone at (647) 999-3203
Recall details
- Recall number
- Z-0134-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 13, 2024
- Posted by the FDA
- Oct 18, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1373 units
- Product code
- GEX
- FDA submissions
- K221306
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Product description
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Code information (models, lots, serial numbers)
UDI 00821925044111 All Serial Numbers:
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SOLTIVE TFL-PLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls450 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95380).
- Z-0135-2025 · Open, ClassifiedSoltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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