FDA-Device2022-11-23Class II
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
Spectranetics Corporation
Hazard
Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.
Sold states
US: LA, MO, TN, CA, NC, PA, HI, AZ, CO, OK, FL, TX, MN, MI, VA, CT, NY, MD, IL, NJ, MA, KS, ME, AR, IA, IN, GA, ID, OR. OUS: DE, GB, ES, SE, IT, RS, GR, IN, FR, IL, DK, SA
Affected count
113
Manufactured in
9965 Federal Dr, N/A, Colorado Springs, CO, United States
Products
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0221-2023Don't want to check this manually?
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