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.
What this means for you
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
- Hazard
- electrical-incompatibility
- electrical-hazard
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.
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