SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Reported: April 3, 2024 Initiated: January 29, 2024 #Z-1385-2024
Product Description
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Reason for Recall
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 203 Units (OUS Only)
- Distribution
- Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
SOLTIVE Premium SuperPulsed Laser (TFL-PLS ). Recalled by Olympus Corporation of the Americas. Units affected: 203 Units (OUS Only).
Why was this product recalled? ▼
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1385-2024.
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