Soltive Premium SuperPulsed Laser System Wireless Footswitch Pairing Difficulties
The Soltive Premium SuperPulsed Laser System may experience difficulties pairing its wireless footswitch, potentially delaying surgical procedures. The recall affects units distributed worldwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with no reported injuries or illnesses. The hazard is an operational issue—difficulties pairing the wireless footswitch—that could delay surgical procedures but does not present direct patient harm.
Plain-English summary
The Soltive Premium SuperPulsed Laser System, Model TFL-PLS, manufactured by Olympus Corporation of the Americas, is being recalled. The device may experience difficulties in pairing the wireless footswitch, which could potentially delay surgical procedures.
This Class II recall affects 1,585 units distributed worldwide, including the United States and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore. All serial numbers of this model are included in the recall.
Users of the Soltive Premium SuperPulsed Laser System should contact Olympus Corporation of the Americas for further information regarding this recall.
The recalled product
- Product
- Soltive Premium SuperPulsed Laser System, Model TFL-PLS
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Surgical Laser
- Affected units
- 1,585
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: TFL-PLS
- UDI-DI: 00821925044111
- Serial Numbers: All Serial Numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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