FDA recall Z-1351-2022

Spectranetics Corporation · Class II · device

Product

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.

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

Key facts

Status: Ongoing
Initiation date: 2022-06-01
Report date: 2022-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Colorado Springs, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1351-2022