Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Laser System Recalled by Spectranetics Corporation Due to Laser System may detect Error 106 or Error...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spectranetics Corporation directly.
Affected 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.
Quantity: 113
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 30 states: AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MO, NJ, NY, NC, OK, OR, PA, TN, TX, VA
About Spectranetics Corporation
Spectranetics Corporation has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report