# FDA recall Z-1351-2022

> **Spectranetics Corporation** · Class II · device recall initiated 2022-06-01.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1351-2022
- **Recalling firm:** Spectranetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-01
- **Report date:** 2022-07-20

- **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-1351-2022

## Citation

> AI Analytics. FDA recall Z-1351-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1351-2022. Source: US FDA. Licensed CC0.

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