The Recall Desk

Manufacturer

Ra Medical Systems, Inc.

7 recalls in our database name Ra Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2020-12-23

Of the 7 recalls from Ra Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-0569-2021·2020-12-23

    Ra Medical Systems Recalls DABRA Laser Due to Footswitch Defect

    Ra Medical Systems is recalling 36 DABRA Laser devices because the footswitch may fail to protect against liquid ingress, potentially causing the laser to remain on.

    Product
    DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0050-2021·2020-10-14

    Ra Medical Systems Recalls DABRA RA-308 Excimer Laser Units

    Ra Medical Systems is recalling 54 DABRA RA-308 Excimer Laser units because a taller wheel mounting may cause the device to fall over, potentially injuring users or patients.

    Product
    DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusive peripheral vascular disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2020·2020-07-15

    Ra Medical Systems Recalls DABRA Laser Due to Software Issue

    Ra Medical Systems is recalling 79 DABRA Laser units because a software issue could cause unintended laser light release, potentially injuring users or patients.

    Product
    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 optica
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-2006-2020·2020-05-20

    Ra Medical Systems Recalls DABRA Catheters Due to Calibration Failure Risk

    Ra Medical Systems is recalling DABRA catheters because the actual shelf life is shorter than labeled, potentially causing calibration failures.

    Product
    Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2020·2020-04-08

    Ra Medical Systems Recalls Pharos Excimer Laser Due to Software Error

    Ra Medical Systems is recalling 10 Pharos EX-308 Excimer Laser units because a software error may prevent the device from stopping, potentially causing skin burns.

    Product
    Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2218-2019·2019-08-14

    Ra Medical Systems Recalls DABRA Laser Units for Calibration Failure

    Ra Medical Systems is recalling four DABRA Laser units because they failed to calibrate during setup. The devices were distributed in California and Pennsylvania.

    Product
    The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the peripheral arteries to cross them. The system is a self-contained unit that consists of a light source unit and a single use catheter. The
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2123-2014·2014-08-06

    Ra Medical Systems Recalls PHAROS EX-308 Excimer Lasers Due to Calibration Defect

    Ra Medical Systems is recalling 435 PHAROS EX-308 Excimer Lasers because they may calibrate with the iris closed.

    Product
    PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
    Category
    Medical Device
    Distribution
    Distributed nationwide