Reported Jul 15, 2020 · Terminated
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and…
Ra Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ra Medical Systems, Inc. · 2070 Las Palmas Dr · Carlsbad, CA · 92011-1518
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Number(s)RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted
- Amount recalled
- 79 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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