Z-2497-2020Class II

DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light...

Name: Z-2497-2020 DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light...
Creator: Ra Medical Systems, Inc.
Published: 2020-01-23
License: https://open.fda.gov/license/

Ra Medical Systems,Inc / initiated 2020-01-23 / Terminated / root cause: software

FDA source

Ra Medical Systems, Inc. began a recall of 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... on 2020-01-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2497-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-23
Posted: 2020-07-04
Terminated: 2021-11-01
Recalling firm: Ra Medical Systems,Inc
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.
Product code: PDU Catheter For Crossing Total Occlusions
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.
Root cause tag: software
FDA root cause: Software design
Action: The Urgent Medical Device Correction notification was sent as certified mail USPS letter to consignees on 1/31/2020. The requested actions are as follows: 1. Do not use the excimer laser until a service technician has installed the new version of software to correct the issue. 2. Complete and return the acknowledgement form, whether you have any of the affected product or not, indicating: * Whether you have the excimer laser in question at your facility, *If you do have the excimer laser, the physical address where the product is located; and, *The person to be contacted to schedule a service call to correct the issue. Should you have any questions or need further assistance call (442) 325-5044.
Quantity in commerce: 79 units
Distribution: US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan.
Product codes and lots: Serial Number(s): RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2497-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2497-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code PDU

K170349Class IIRA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc / cleared 2017-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)