Food, drugs, devices › Ra Medical Systems, Inc.
Device recall: DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusi
FDA enforcement event 86217 is a device recall by Ra Medical Systems, Inc. of Carlsbad, CA, initiated 24 Jul 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 9 Aug 2023. Initiation: voluntary: firm initiated. Ra Medical Systems, Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ra Medical Systems, Inc., Carlsbad, CA.
Reason for recall
"Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury."
Distribution
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0050-2021 | DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease. | 54 units | Class II | Terminated | 14 Oct 2020 |
Context
Other enforcement events for Ra Medical Systems, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Oct 2020 | DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. | Device | Class II | 1 |
| 23 Jan 2020 | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and | Device | Class II | 1 |
| 19 Sep 2019 | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018- | Device | Class II | 1 |
| 23 Aug 2019 | Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the ski | Device | Class II | 1 |
| 15 Feb 2018 | The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occl | Device | Class II | 1 |
| 30 Jun 2014 | PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and | Device | Class II | 1 |
All 7 events for Ra Medical Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Aug 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.