Agency classClass IIOur severity:High FDA (Devices)·Z-1385-2024·Announced 2024-04-03

SOLTIVE Premium SuperPulsed Laser Recalled for Incompatible Power Cord

Olympus recalls the SOLTIVE Premium SuperPulsed Laser due to non-compliant power cords incompatible with regional electrical outlets. Approximately 203 units were distributed to Australia, Chile, Germany, Hong Kong, Japan, New Zealand, and Singapore.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a medical laser device with electrical plug incompatibility in specific regions. No adverse events or injuries have been reported, classifying this as a theoretical risk-of-harm scenario.

Plain-English summary

The SOLTIVE Premium SuperPulsed Laser (model TFL-PLS), manufactured by Olympus Corporation of the Americas, has been recalled due to non-compliant power cords. Approximately 203 units were supplied with power cords that do not meet the electrical plug configurations required in their respective regions.

The recalled units were distributed outside the United States to Australia, Chile, Germany, Hong Kong, Japan, New Zealand, and Singapore. All serial numbers of the TFL-PLS model are affected. A non-compliant power cord creates a potential electrical safety risk, as users in these regions may have difficulty connecting the device properly.

Consumers in affected regions who have received this device should contact Olympus Corporation of the Americas for instructions on obtaining a compliant replacement power cord suitable for their regional electrical standards.

The recalled product

Product: SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Laser Equipment
Hazard: electrical-incompatibility
electrical-hazard
Affected units: 203

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Model Number: TFL-PLS
UDI/DI: 00821925044111
All serial numbers.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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