PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 20, 2022 Initiated: June 1, 2022 #Z-1351-2022

Product Description

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

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.

Details

Recalling Firm
Spectranetics Corporation
Units Affected
105 units
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
Location
Colorado Springs, CO

Frequently Asked Questions

What product was recalled?
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM. Recalled by Spectranetics Corporation. Units affected: 105 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1351-2022.