Reported Jul 20, 2022 · Ongoing
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC,…
Spectranetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectranetics Corporation · 9965 Federal Dr · Colorado Springs, CO · 80921-3822
Is this the product you have?
- Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
- Lot codes and dates
- Serial Numbers100000
- to 100104 UDI/DI(01)00813132027452
- Amount recalled
- 105 units
Where it was sold
Why it was recalled
The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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