UnratedMedical device recall · FDA · Published February 15, 2018
Ra Medical Systems Recalls DABRA Laser Model RA-308: Laser Calibration Issue
Ra Medical Systems recalls DABRA Laser (model RA-308) due to potential laser calibration errors during setup, which could affect medical procedures. Affected units have specific serial numbers.
“Ra Medical Systems Recalls DABRA Laser Model RA-308: Laser Calibration Issue.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71951-ra-medical-systems-recalls-dabra-laser-model-ra-308-laser. Based on FDA recall #Z-2218-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2218-2019%22&limit=1).
Ra Medical Systems, Inc. recalled The DABRA Laser (model RA-308) on Feb. 15, 2018, according to the FDA. The hazard is that lasers and catheters did not calibrate during setup prior to use.
How to tell if you have it
Brand: Ra Medical Systems
Product: The DABRA Laser (model RA-308)
Serial Numbers: 0016, 0039, 0044, 0048
Quantity: 4 units
Distribution: U.S. (CA, PA)
The hazard
The DABRA Laser system consists of a light source unit and a single-use catheter designed to provide ultraviolet laser energy endovascularly. The recall was issued because the lasers and catheters did not calibrate during setup prior to use.
Context
GovInfoNow's records show Ra Medical Systems, Inc. has had five other recalls since Aug. 23, 2019. Other recent recalls of similar products include Lutronic CLARITY II Laser System Model 1110200210 Sparks and May Burn Patients (Jan. 27, 2026), Lutronic DermaV Laser System Recall: Risk of Patient Burn During Treatment (Aug. 6, 2026), and Daavlin Photera 600 UV Lamp: Incorrect UV Output Calibration Risk (March 5, 2026).
How to tell if you have this one
Check for the model RA-308 with serial numbers 0016, 0039, 0044, or 0048. The device is used for medical procedures involving vascular treatments.
Brand
Ra Medical Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Verify the serial number on the device to confirm if it is one of the affected units: 0016, 0039, 0044, or 0048.
Where it went and when
Where it was distributed
Distributed in California and Pennsylvania.
Listed by the agency
Not listed
FDA distribution: “U.S: CA, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Pennsylvania.
Recall timeline
FDA published this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2218-2019 (February 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2218-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.