The Recall Desk
HighFDA (Devices)·Z-0050-2021·Announced 2020-10-14

Ra Medical Systems Recalls DABRA RA-308 Excimer Laser Units

Ra Medical Systems is recalling 54 DABRA RA-308 Excimer Laser units because a taller wheel mounting may cause the device to fall over, potentially injuring users or patients.

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 risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury without confirmed incidents.

Plain-English summary

Ra Medical Systems, Inc. is recalling 54 units of the DABRA RA-308 Excimer Laser. The device is intended for use in ablating a channel in occlusive peripheral vascular disease. The recall is due to a design issue where the taller wheel mounting on the laser may cause the device to fall over, potentially causing user or patient injury.

The affected units were distributed worldwide, including nationwide in the United States and in Japan. The specific serial numbers for the recalled units are listed in the agency's official recall record Z-0050-2021.

Healthcare providers and users should stop using the affected devices immediately. Ra Medical Systems is the recalling firm responsible for managing the recall.

The recalled product

Product
DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
Manufacturer
Ra Medical Systems, Inc.
Category
Medical Device — Laser Therapy
Hazard
Affected units
54

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)

  • Model Number DABRA Excimer Laser RA-308
  • Serial Numbers: RA00027
  • RA00039
  • RA00046
  • RA00049
  • RA00050
  • RA00054
  • RA00055
  • RA00056
  • RA00057
  • RA00058
  • RA00063
  • RA00064
  • RA00065
  • RA00067
  • RA00069
  • RA00070
  • RA00073
  • RA00074
  • RA00081

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Related recalls

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