Skip to content

SOLTIVE recallZ-1384-2024 · Olympus Corporation of the Americas · initiated Jan 29, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1384-2024
Status
Open, Classified
Initiated by the company
Jan 29, 2024
Posted by the FDA
Mar 27, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
17 Units (OUS Only)
Product code
GEX
FDA submissions
K221306
Distribution
Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.

Product description

SOLTIVE Pro SuperPulsed Laser (TFL-SLS )

Code information (models, lots, serial numbers)

Model Number: TFL-SLS; UDI/DI: 00821925044135; All serial numbers.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94125).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page