Recall Z-0569-2021— Ra Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Ra Medical Systems, Inc., initiated 2020-10-16, terminated 2023-01-11. It names one FDA 510(k) clearance: K170349. Product: DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.. Reason: Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase..
- Recalling firm
- Ra Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-16
- Terminated
- 2023-01-11
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Reason for recall
Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.
Data sourced from openFDA. This site is unofficial and independent of the FDA.