Recall Z-0050-2021— Ra Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Ra Medical Systems, Inc., initiated 2020-07-24, terminated 2023-08-09. It names one FDA 510(k) clearance: K170349. 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: Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury..
- Recalling firm
- Ra Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-24
- Terminated
- 2023-08-09
- 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.