Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
FDA Recall Z-0134-2025 · Posted 2024-10-18
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2024-08-13
Product Quantity1373 units
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.
Firm Action
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
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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