Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Recall
- Recall Number
- Z-0135-2025
- Event Number
- 95380
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- GEX
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 13, 2024
- Posted
- October 18, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
Description
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
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.
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
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
159 units