Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and

FDA device recall Z-0135-2025 · posted 2024-10-18 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEX

Quantity affected

159 units

Distribution

Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.

Date initiated

2024-08-13

Date posted

2024-10-18

Location

Center Valley, PA

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