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Recall Observatory FDA recall evidence

Device product

Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

Z-1351-2022

June 01, 2022

Class II

Product summary

Firm
Spectranetics Corporation
Event
Event 90364
Status
Ongoing
Classification
Class II
Quantity
105 units
Official record key
device-enforcement:Z-1351-2022

Official wording

Reason: 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.

Code information: Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.