DABRA Laser recall: Software Issue
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively…
Why was DABRA Laser 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number(s): RA00027 through RA00176;all DABRA excimer laser RA-308 product is impacted.
- Product
- DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively…
- Recalling firm
- Ra Medical Systems, Inc.
- Quantity
- 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.
- Recall date
- July 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)