DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Reported: October 14, 2020 Initiated: July 24, 2020 #Z-0050-2021
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.
Details
- Recalling Firm
- Ra Medical Systems, Inc.
- Units Affected
- 54 units
- 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.
- Location
- Carlsbad, CA
Frequently Asked Questions
What product 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.. Recalled by Ra Medical Systems, Inc.. Units affected: 54 units.
Why was this product recalled? ▼
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0050-2021.
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