# FDA recall Z-0221-2023

> **Spectranetics Corporation** · Class II · device recall initiated 2022-10-14.

## 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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0221-2023
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-14
- **Report date:** 2022-11-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Colorado Springs, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0221-2023

## Citation

> AI Analytics. FDA recall Z-0221-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0221-2023. Source: US FDA. Licensed CC0.

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