Recall Z-0221-2023— Spectranetics Corporation
Class II · Ongoing
Class II FDA medical device recall by Spectranetics Corporation, initiated 2022-10-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Spectranetics Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-14
- Firm location
- Colorado Springs, CO, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.