CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report

Dabra RA-308 Excimer Laser, SN: ******* recalled by Ra Medical Systems

Ra Medical Systems is recalling Dabra RA-308 Excimer Laser, SN: *******, distributed nationwide in the US. The recall was initiated on 24 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled54 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0050-2021
FDA event ID: 86217
Recalling firm: Ra Medical Systems, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Jul 2020
FDA classified: 2 Oct 2020
Reported: 14 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

24 Jul 2020	Recall initiated by company
2 Oct 2020	Classified by FDA	+70 days
14 Oct 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arizona California Florida Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan North Carolina Nevada New York Oklahoma Oregon Pennsylvania Texas

Questions about this recall

Is Dabra RA-308 Excimer Laser, SN: ******* recalled?

Yes. Ra Medical Systems recalled Dabra RA-308 Excimer Laser, SN: ******* on 24 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-0050-2021.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ra Medical Systems

All 7

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Device	CLASS II	Dabra Laser (RA-308 Excimer Laser) recalled by Ra Medical Systems	Ra Medical Systems	Other	16 states
15 Jul 2020Device	CLASS II	Dabra Laser (RA-308 Excimer Laser) recalled by Ra Medical Systems	Ra Medical Systems	Device Malfunction	22 states
20 May 2020Device	CLASS II	Dabra Catheter 5F recalled by Ra Medical Systems	Ra Medical Systems	Sterility	Nationwide
8 Apr 2020Device	CLASS II	Pharos Excimer Laser recalled by Ra Medical Systems	Ra Medical Systems	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS II	The Dabra Laser recalled by Ra Medical Systems	Ra Medical Systems	Device Malfunction	CA, PA

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