Philips Laser System — Class II medical device recall Z-1351-2022
Ongoing recall by Spectranetics Corporation, reported 2022-07-20, distributed in AR, AZ, CA, CO, CT, FL, GA, HI…. The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an erro
| Recall number | Z-1351-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectranetics Corporation, Colorado Springs, CO, United States |
| Recall initiated | 2022-06-01 |
| Classified | 2022-07-11 |
| Reported by FDA | 2022-07-20 |
| Distributed | 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 |
| Countries outside the US | DK, ES, FR, GB, GR, IN, IT, NL, RS, SA, SE |
| Quantity | 105 units |
| UPC / GTIN / UDI-DI | 00813132027452 |
| Serial numbers | 100000, 100104 |
| Model numbers | LAS-100 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1351-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.