Reported Dec 23, 2020 · Terminated
DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular…
Ra Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ra Medical Systems, Inc. · 2070 Las Palmas Dr · Carlsbad, CA · 92011-1518
Is this the product you have?
- DABRA Laser (RA-308
- Excimer Laser) Intended UseFor use in ablating a channel in occlusive peripheral vascular disease
- IndicationsFor crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease
- Lot codes and dates
- Model
- Number RA-308 Product/Catalog Number1200-0001-01
- Serial Numbers
RA00027RA00046RA00049RA00050RA00054RA00056RA00057RA00058RA00064RA00069RA00073RA00081RA00083RA00084RA00085RA00089RA00097RA00098RA00114RA00115RA00120RA00121RA00125RA00127RA00135RA00138RA00148RA00153RA00154RA00160RA00164RA00165RA00167RA00170RA00175and RA00177
- Amount recalled
- 36 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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