DABRA Laser — Class II medical device recall Z-2497-2020
Terminated recall by Ra Medical Systems, Inc., reported 2020-07-15, distributed in AL, AZ, CA, FL, GA, ID, IL, IN…. A software issue was identified which could result in user or patient injury, or may adversely impact laser pe
| Recall number | Z-2497-2020 |
|---|---|
| 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 | 2020-01-23 |
| Classified | 2020-07-04 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-11-01 |
| Distributed | AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, NC, NV, NY, OK, OR, PA, TN, TX, WI |
| Countries outside the US | IT, JP |
| Quantity | 79 units |
| Reason classes | software |
| Serial numbers | RA00027 |
Product
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with existing endovascular accessories and tools to complete a surgical procedure. The software is programmed onto an EEPROM chip, which is a component of the DABRA Excimer Laser RA-308 system. Catheter for crossing total occlusions in vascular system.
Reason for recall
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
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-2497-2020. 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.