Device recall: DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source…
Class II FDA enforcement event 85790. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.
Class II, in the words of FDA
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
Ra Medical Systems, Inc. started this device recall on 23 Jan 2020. The firm address in the FDA record is in Carlsbad, CA. FDA put the recall in Class II. FDA event 85790 has 1 product record. The first FDA enforcement report date is 15 Jul 2020. The record gives the status Terminated, with the termination date 1 Nov 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan.
Recalling firm
Ra Medical Systems, Inc., Carlsbad, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2497-2020 | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with… | 79 units | Class II | Terminated | 15 Jul 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| 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 |
| 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 |
Official channels
- FDA enforcement report Z-2497-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 85790. https://recallregister.com/fda/ii/85790/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US: AL, AZ, CA, FL, GA, ID, IL, IN, KS, KY, LA, MI, MD, NC, NV, NY, OK, OR, PA, TN,TX, WI. OUS: Italy and Japan.
- What quantity of product is in FDA event 85790?
- The FDA record gives this quantity:
79 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.