Ra Medical Systems, Inc. recalls DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlus…

Recall date

July 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0050-2021

FDA classification

Class II

Brand / firm

Ra Medical Systems, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, NC, NV, NY, OR, OK, PA, TX, WA and the country of Japan.

Why it was recalled

Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.