Olympus SOLTIVE Premium laser system recalled for defective power supply
What this means
Olympus identified a defect in the 24V power supply module in some SOLTIVE Premium laser systems that may cause the device to stop working. In some cases, smoke or a burning smell may occur inside the laser console, though the design contains any smoke within the internal enclosure where it will self-extinguish.
- Check if your Olympus SOLTIVE laser system serial number matches the affected list
- Stop using the device immediately if your serial number is listed
- Contact Olympus Corporation of the Americas for instructions on repair or replacement
The agency's original wording
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2026More Olympus recalls
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