Soltive Premium Laser (Olympus) - Translation Error (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
UDI 00821925044111 All Serial Numbers:
Products Sold
UDI 00821925044111 All Serial Numbers:
Olympus Corporation of the Americas is recalling Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulatio due to The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Cynthia.Ow@Olympus.com or by phone at (647) 999-3203
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026