Olympus Corporation of the Americas: Soltive Laser Systems and Wireless Footswitch Recalled for Pairing Difficulties

Agency Publication Date: August 5, 2024

Summary

Olympus is recalling 3,676 units of its Soltive SuperPulsed Laser Systems (Premium and Pro models) and associated Wireless Footswitches because the footswitch may fail to pair with the laser system. This defect can occur unexpectedly and leads to delays in surgical procedures while medical staff troubleshoot the connection. Affected models include the Soltive Premium (Model TFL-PLS), Soltive Pro (Model TFL-SLS), and the Wireless Footswitch (Model TFL-AFSWL). You should contact your healthcare provider or Olympus for specific instructions regarding the continued use or repair of these devices.

Risk

The wireless footswitch may fail to connect to the laser console, which can prevent the laser from being activated as intended. This failure can cause critical delays during surgery, potentially extending the time a patient is under anesthesia or requiring a change in surgical approach.

What You Should Do

Identify your device by checking the model and UDI-DI on the product label: Soltive Premium (Model TFL-PLS, UDI-DI 00821925044111), Soltive Pro (Model TFL-SLS, UDI-DI 00821925044135), or Wireless Footswitch (Model TFL-AFSWL, UDI-DI 00821925044258).
Confirm if your unit is affected by checking the serial number; this recall applies to all serial numbers for the models listed above.
Review the notification letter sent by Olympus on May 31, 2024, for specific technical instructions on how to handle pairing difficulties in a clinical setting.
Contact Olympus Corporation of the Americas at their Center Valley, PA headquarters or through your local representative for further technical guidance and to confirm if a software or hardware update is required.
Contact your healthcare provider or facility biomedical engineering department if you experience repeated pairing failures with the Soltive system.
For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer guidance and technical support

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Soltive Premium SuperPulsed Laser System

Model / REF:

TFL-PLS

UDI-DI: 00821925044111

Lot Numbers:

All Serial Numbers

Product: Soltive Pro SuperPulsed Laser System

Model / REF:

TFL-SLS

UDI-DI: 00821925044135

Lot Numbers:

All Serial Numbers

Product: Soltive SuperPulsed Laser System Wireless Footswitch

Model / REF:

TFL-AFSWL

UDI-DI: 00821925044258

Lot Numbers:

All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94964

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized Medical Distributors

Manufactured In: United States

Units Affected: 3 products (1,585 Units; 253 Units; 1,838 Units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your device by checking the model and UDI-DI on the product label: Soltive Premium (Model TFL-PLS, UDI-DI 00821925044111), Soltive Pro (Model TFL-SLS, UDI-DI 00821925044135), or Wireless Footswitch (Model TFL-AFSWL, UDI-DI 00821925044258).

Confirm if your unit is affected by checking the serial number; this recall applies to all serial numbers for the models listed above.

Review the notification letter sent by Olympus on May 31, 2024, for specific technical instructions on how to handle pairing difficulties in a clinical setting.

Contact Olympus Corporation of the Americas at their Center Valley, PA headquarters or through your local representative for further technical guidance and to confirm if a software or hardware update is required.

Contact your healthcare provider or facility biomedical engineering department if you experience repeated pairing failures with the Soltive system.

For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Soltive Premium SuperPulsed Laser System

Model / REF:

TFL-PLS

UDI-DI: 00821925044111

Lot Numbers:

All Serial Numbers

Product: Soltive Pro SuperPulsed Laser System

Model / REF:

TFL-SLS

UDI-DI: 00821925044135

Lot Numbers:

All Serial Numbers

Product: Soltive SuperPulsed Laser System Wireless Footswitch

Model / REF:

TFL-AFSWL

UDI-DI: 00821925044258

Lot Numbers:

All Serial Numbers