Z-1351-2022 Class II Ongoing

Recalled by Spectranetics Corporation — Colorado Springs, CO

Recall Details

Product Type
Devices
Report Date
July 20, 2022
Initiation Date
June 1, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
105 units

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.

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

Code Information

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