Spectranetics Corporation: Medical Device Recall in 2022 - (Recall #: Z-1351-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 1, 2022

Date Posted: July 20, 2022

Recall Number: Z-1351-2022

Event ID: 90364

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.

Status: Ongoing

Product Quantity: 105 units

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

Voluntary or Mandated:

Voluntary: Firm initiated