The Recall Desk
HighFDA (Devices)·Z-1384-2024·Announced 2024-04-03

SOLTIVE Pro SuperPulsed Laser recalled for non-compliant power cord

Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.

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 medical device with a potential electrical safety hazard from a non-compliant power cord lacking proper regional plug configurations. No injuries or illnesses reported; the hazard remains theoretical.

Plain-English summary

Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser (TFL-SLS), a medical laser device. Seventeen units distributed to Australia, Chile, Germany, Hong Kong, Japan, New Zealand, and Singapore are affected.

The devices have a non-compliant power cord that may lack the proper Type B or Type E/F electrical plug configurations required for the regions in which they were supplied. This incompatibility creates a potential electrical hazard.

No injuries or illnesses have been reported. The recall covers all serial numbers of the affected Model Number TFL-SLS devices.

The recalled product

Product
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Laser
Hazard
  • electrical-safety
  • power-cord

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-SLS
  • UDI/DI: 00821925044135
  • All serial numbers.

Distribution

Distribution scope not specified by the agency.

Related recalls

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