Ra Medical Systems Recalls DABRA Laser Due to Software Issue
Ra Medical Systems is recalling 79 DABRA Laser units because a software issue could cause unintended laser light release, potentially injuring users or patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Ra Medical Systems, Inc. is recalling 79 units of the DABRA Laser (RA-308 Excimer Laser) and DABRA Catheter system. The recall is due to a software issue that could adversely impact laser performance or result in user or patient injury.
The DABRA Laser System is an excimer laser ultraviolet light source and delivery system designed to ablate unwanted material at the surgical site. The software issue creates a risk that an unintended release of laser light (radiation) may occur, which could injure the user or patient.
The affected units have serial numbers ranging from RA00027 through RA00176. The products were distributed in the United States (AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN, TX, WI) and internationally in Italy and Japan. Users should contact Ra Medical Systems, Inc. for further instructions on how to proceed with the recall.
The recalled product
- 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 optica
- Manufacturer
- Ra Medical Systems, Inc.
- Category
- Medical Device — Laser System
- Affected units
- 79
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Number(s): RA00027 through RA00176
- all DABRA excimer laser RA-308 product is impacted.
Distribution
Related recalls
Same manufacturer · Ra Medical Systems, Inc.
See all →- HighRa Medical Systems Recalls DABRA Laser Due to Footswitch Defect
FDA (Devices) · 2020-12-23
- HighRa Medical Systems Recalls DABRA RA-308 Excimer Laser Units
FDA (Devices) · 2020-10-14
- ModerateRa Medical Systems Recalls DABRA Catheters Due to Calibration Failure Risk
FDA (Devices) · 2020-05-20
- HighRa Medical Systems Recalls Pharos Excimer Laser Due to Software Error
FDA (Devices) · 2020-04-08
- ModerateRa Medical Systems Recalls DABRA Laser Units for Calibration Failure
FDA (Devices) · 2019-08-14
Same hazard · laser radiation
See all →- HighIntegre Pro Laser Ophthalmoscope Systems: Risk of Unintended Laser Emission
FDA (Devices) · 2023-07-05
- HighRAPTAR Laser Range Finders Recalled for Field Modification Safety Risk
FDA (Devices) · 2021-11-03
- HighDeWALT and Stanley Laser Distance Measurers Recalled for Excessive Radiation
FDA (Devices) · 2020-01-08
- HighGk Photonics Spectrum Laser Projection Series Recalled for Safety Defect
FDA (Devices) · 2019-08-14
- SevereGk Photonics ClubMax Laser Projectors Recalled for Safety Interlock Defect
FDA (Devices) · 2019-08-14