Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Reported: August 14, 2024 Initiated: May 31, 2024 #Z-2504-2024
Product Description
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Reason for Recall
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 1,585 Units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Soltive Premium SuperPulsed Laser System, Model TFL-PLS. Recalled by Olympus Corporation of the Americas. Units affected: 1,585 Units.
Why was this product recalled? ▼
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2024. Severity: Moderate. Recall number: Z-2504-2024.
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