Reported Oct 14, 2020 · Terminated
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in…
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 RA-308 Excimer Laser
- SN******* -
- Product UsageThe device is intended for use in ablating a channel in occlusive peripheral vascular disease
- Lot codes and dates
- Model Number DABRA Excimer Laser RA-308
- Serial Numbers
RA00027RA00039RA00046RA00049RA00050RA00054RA00055RA00056RA00057RA00058RA00063RA00064RA00065RA00067RA00069RA00070RA00073RA00074RA00081RA00082RA00083RA00084RA00085RA00086RA00088RA00089RA00097RA00098RA00103RA00114RA00115RA00117RA00118RA00120RA00121RA00124RA00125RA00127RA00135RA00136RA00137RA00138RA00143RA00147RA00148RA00153RA00154RA00160RA00164RA00165RA00167RA00170RA00175and RA00177
- Amount recalled
- 54 units
Where it was sold
Why it was recalled
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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