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Spectranetics Corporation recalls Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60H
Recalled July 20, 2022 · FDA recall Z-1351-2022 · Spectranetics
Hazard
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. · FDA Class II
Units
105 units
Sold at
US: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN TX VA OUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom
Description
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.
Product
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Manufacturer(s)
Spectranetics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →