DABRA Laser — Class II medical device recall Z-0569-2021
Terminated recall by Ra Medical Systems, Inc., reported 2020-12-23, distributed in AL, AZ, CA, FL, IL, IN, KY, LA…. Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spil
| Recall number | Z-0569-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ra Medical Systems, Inc., Carlsbad, CA, United States |
| Recall initiated | 2020-10-16 |
| Classified | 2020-12-14 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2023-01-11 |
| Distributed | AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, WA |
| Countries outside the US | JP |
| Quantity | 36 devices |
| Reason classes | device malfunction |
| NDC | 01200-0001-01 |
| Serial numbers | RA00027, RA00046, RA00049, RA00050, RA00054, RA00056, RA00057, RA00058, RA00064, RA00069, RA00073, RA00081, RA00083, RA00084, RA00085, RA00089, RA00097, RA00098, RA00114, RA00115, RA00120, RA00121, RA00125, RA00127, RA00135 and 11 more |
| Model numbers | 1200-0001-01, RA-308 |
Product
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Reason for recall
Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.
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-0569-2021. 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.