Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:

FDA device recall Z-1715-2025 · posted 2025-05-01 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Preset treatment parameters are not consistently being used in accordance with the IFU.

Action taken

On April 4, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Olympus will contact you to schedule time for an Olympus Field Representative to visit your facility and install the software update. Additionally, Olympus requires you to take the following actions: 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. 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: "0469 c. Complete the form as instructed. 5. Olympus will contact you to schedule time for an Olympus Field Representative to visit your facility and install the software update. Olympus s record of the completed software update on your SOLTIVE system(s) will serve as the acknowledgment of this field corrective action for your facility. 6. Following the installation of the software update on your SOLTIVE system(s), ensure all personnel are thoroughly trained on the attached IFU Addendum corresponding with this update. The updated version of the full IFU can be located electronically at OlympusConnect.com. If you would like to receive a physical copy of the updated IFU, please submit a request in the comments of our recall portal when submitting your acknowledgement. 7. If you have further distributed this product, identify and forward them this notification. Olympus requests that you report any complaints related to the SOLTIVE Laser System or any associated injuries to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may al

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

GEX

Quantity affected

189

Distribution

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

Date initiated

2025-04-04

Date posted

2025-05-01

Location

Center Valley, PA

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