The Recall Desk
HighFDA (Devices)·Z-0569-2021·Announced 2020-12-23

Ra Medical Systems Recalls DABRA Laser Due to Footswitch Defect

Ra Medical Systems is recalling 36 DABRA Laser devices because the footswitch may fail to protect against liquid ingress, potentially causing the laser to remain on.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to unintended laser operation, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Ra Medical Systems, Inc. is recalling 36 units of the DABRA Laser (RA-308 Excimer Laser). The recall is due to a defect in the footswitch, which does not meet the required specifications for protection against the ingress of solids or liquids.

If liquids are spilled near or on the footswitch, the device may fail in the 'on' position. This failure could allow the laser to continue operating unintentionally. The affected devices were distributed in the United States to the states of Alabama, Arizona, California, Florida, Illinois, Indiana, Kentucky, Louisiana, Maryland, North Carolina, Nevada, New York, Oklahoma, Oregon, Texas, and Washington, as well as to Japan.

The DABRA Laser is intended for use in ablating a channel in occlusive peripheral vascular disease, specifically for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. Users should contact Ra Medical Systems for instructions on how to address this issue.

The recalled product

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.
Manufacturer
Ra Medical Systems, Inc.
Category
Medical Device — Laser Device
Hazard
Affected units
36

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • RA00046
  • RA00049
  • RA00050
  • RA00054
  • RA00056
  • RA00057
  • RA00058
  • RA00064
  • RA00069
  • RA00073
  • RA00081
  • RA00083
  • RA00084
  • RA00085
  • RA00089
  • RA00097
  • RA00098
  • RA00114
  • RA00115
  • RA00120

Distribution

Distributed in 16 states:

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