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Recall Observatory FDA recall evidence

Device product

DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.

Z-0050-2021

July 24, 2020

Class II

Product summary

Firm
Ra Medical Systems, Inc.
Event
Event 86217
Status
Terminated
Classification
Class II
Quantity
54 units
Official record key
device-enforcement:Z-0050-2021

Official wording

Reason: Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

Code information: 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, RA00082, RA00083, RA00084, RA00085, RA00086, RA00088, RA00089, RA00097, RA00098, RA00103, RA00114, RA00115, RA00117, RA00118, RA00120, RA00121, RA00124, RA00125, RA00127, RA00135, RA00136, RA00137, RA00138, RA00143, RA00147, RA00148, RA00153, RA00154, RA00160, RA00164, RA00165, RA00167, RA00170, RA00175, and RA00177.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.