FDA recall Z-0050-2021

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-07-24

Report date

2020-10-14

Termination date

2023-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0050-2021