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Ra Medical Systems, Inc. recalls DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusi
Recalled October 14, 2020 · FDA recall Z-0050-2021 · Ra Medical Systems
Hazard
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. · FDA Class II
Units
54 units
Sold at
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.
Description
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Product
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Manufacturer(s)
Ra Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →