Food, drugs, devices › Ra Medical Systems Inc
Device recall: PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and
Ra Medical Systems Inc (Carlsbad, CA) initiated this device recall on 30 Jun 2014; FDA lists 1 product record under event 68706, classified Class II.
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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 9 Sep 2014. 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
"RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed."
Distribution
"Worldwide Distribution - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2123-2014 | PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma | 435 units | Class II | Terminated | 6 Aug 2014 |
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 |
| 24 Jul 2020 | DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusi | 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 |
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: "RA Medical Systems is recalling the PHAROS EX-308 Excimer Laser because there is a possibility that the laser may calibrate with the iris closed."
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 - USA (Nationwide) and Internationally to: Korea, Kuwait, and Saudi Arabia."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Sep 2014. "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.