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FDA (Device enforcement)Recalled 2022-06-01class ii

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

Is my product affected?

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

  • UPC 00813132027452

Check against the official notice below — it lists the full affected range.

What happened

The Philips Laser System model LAS-100 (REF LAS-100) manufactured by Spectranetics Corporation may detect an inoperable hardware component when powered on, causing an error code to appear that prevents the system from operating until the code is cleared. This issue affects 105 units with serial numbers ranging from 100000 to 100104. The affected devices were distributed across multiple U.S. states (including Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, and Virginia) as well as internationally in Saudi Arabia, Denmark, France, Greece, India, Italy, the Netherlands, Serbia, Spain, Sweden, and the United Kingdom.

The source document does not specify a remedy or corrective action for consumers who possess affected units.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: 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 Quantity: 105 units Lot/code info: Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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