FDA Device recall Z-2497-2020
DABRA Laser (RA-308 Excimer Laser)
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of DABRA Laser (RA-308 Excimer Laser) by Ra Medical Systems, citing 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 (….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2497-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-23 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ra Medical Systems |
| Distribution | AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, NC, NV, NY, OK, OR, PA, TN, TX, WI |
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
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.
Identifiers
| code_info | Serial Number(s): RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2497-2020%22
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