FDA Device recall Z-1351-2022
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM by Spectranetics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1351-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-01 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Spectranetics |
| Distribution | 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 |
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.
Identifiers
| code_info | Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1351-2022%22
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