Recall Z-1351-2022— Spectranetics Corporation
Class II · Ongoing
Class II FDA medical device recall by Spectranetics Corporation, initiated 2022-06-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM. Reason: 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..
- Recalling firm
- Spectranetics Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-01
- Firm location
- Colorado Springs, CO, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.