Z-1385-2024Class II

SOLTIVE Premium SuperPulsed Laser (TFL-PLS )

Name: Z-1385-2024 SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Creator: Olympus Corporation of the Americas
Published: 2024-01-29
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-01-29 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) on 2024-01-29. FDA classified it as Class II and gives the reason as "A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1385-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-29
Posted: 2024-03-27
Recalling firm: OLYMPUS Corporation of the Americas
Product: SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 203 Units (OUS Only)
Distribution: Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Product codes and lots: Model Number: TFL-PLS; UDI/DI: 00821925044111; All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1385-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1384-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-27
Z-1385-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-27

Product code GEX

K221306Class IISOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesGyrus Acmi, Inc. / cleared 2023-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)