Surgical Laser System Recalled Due to Wireless Footswitch Pairing Difficulties
Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.
What this means for you
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: The FDA classified this as a Class II recall. No illnesses, injuries, or hospitalizations have been reported. The hazard is a functional defect (wireless pairing difficulty) that could delay procedures but does not pose direct patient harm. This qualifies as a Moderate (Score 2) recall.
Plain-English summary
Olympus Corporation of the Americas is recalling the Soltive Pro SuperPulsed Laser System, Model TFL-SLS. The recall is due to difficulties in pairing the wireless footswitch with the laser system, which could potentially delay surgical procedures.
The recalled product includes all serial numbers of the Soltive Pro SuperPulsed Laser System, Model TFL-SLS. A total of 253 units have been distributed worldwide, including distribution in the United States and internationally to Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore.
Healthcare facilities and surgical centers using this equipment should contact Olympus Corporation of the Americas regarding the wireless footswitch pairing issue and request information about available remedies or replacement devices. No patient injuries have been reported in connection with this recall.
The recalled product
- Product
- Soltive Pro SuperPulsed Laser System, Model TFL-SLS
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Surgical Laser
- Hazard
- wireless-pairing-failure
- procedure-delay
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-SLS
- UDI-DI: 00821925044135
- Serial Numbers: All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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