Olympus Corporation of the Americas SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) Recall
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 (TFL-PLS )
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model Number: TFL-PLS, UDI/DI: 00821925044111, All serial numbers.
Products Sold
Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.
Olympus Corporation of the Americas is recalling SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) due to A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Recommended Action
Per FDA guidance
On February 21, 2024, the firm notified customers of the issue via MEDICAL DEVICE CORRECTION letters. Actions to be taken by the customer: 1. Ensure all personnel, including clinical staff, are completely knowledgeable and thoroughly aware of the contents of this letter. 2. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number and provide your contact information as indicated in the portal. 3. Confirm that the installed power cord meets the specifications detailed in this letter via your Biomedical Department or other appropriate personnel. You may continue using your Soltive Laser System after confirming the specifications of the power cord. 4. If you have questions regarding the specifications of the power cord, are unable to confirm the specifications, or if you identify that the cord does not meet the specifications, quarantine your Soltive Laser System and contact your local Olympus representative to receive additional guidance and/or to schedule an immediate on-site inspection. 5. Olympus Service will reach out to you to schedule an on-site service to inspect the power cord. If the power cord is found to be non-compliant, it will be replaced at no cost to you. Olympus requests you to report any complaints, including any injuries associated with the Soltive Laser, to your Regional Complaint Intake Contact. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, please contact the regional contact for Olympus provided in the letter.
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 noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026