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Ra Medical Systems, Inc

United StatesFDA applicant, unverified

Devices
4
FDA recalls
7

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue4

Newest first, rows 1-4 of 4

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 2
  • 2020 3
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2020

    • 16 Oct 2020 Z-0569-2021 Class II Terminated Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase. Distribution: US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country:…
      Full distribution text US Distribution to states of: AL, AZ, CA, FL, IL, IN, KY, LA, MD, NC, NV, NY, OK, OR, TX, and WA; and to OUS country: Japan.
      Submission number: K170349
    • 24 Jul 2020 Z-0050-2021 Class II Terminated 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,…
      Full distribution text 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.
      Submission number: K170349
    • 23 Jan 2020 Z-2497-2020 Class II Terminated 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. 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. Submission number: K170349

  • 2019

    • 19 Sep 2019 Z-2006-2020 Class II Terminated The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life. Distribution: Worldwide Distribution - US Nationwide - MI, TN, CA, FL, OR, PA, AZ, AL, VA, GA, TX, ID, AR, NC, IN, SC, CT, NY, KS, LA,…
      Full distribution text Worldwide Distribution - US Nationwide - MI, TN, CA, FL, OR, PA, AZ, AL, VA, GA, TX, ID, AR, NC, IN, SC, CT, NY, KS, LA, NV, MS, NE, MD, IL, OK, MA, WA, MO, WI, KY. OUS - Netherlands, Pakistan, United Kingdom, Italy, France
      Submission number: K170349
    • 23 Aug 2019 Z-1631-2020 Class II Terminated At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters. Distribution: U.S. Nationwide distribution in the states of CA, FL, OR, MS, NY. Submission number: K062963

  • 2018

    • 15 Feb 2018 Z-2218-2019 Class II Terminated Lasers/Catheters did not calibrate during set-up prior to use. Distribution: U.S: CA, PA Submission number: K170349

  • 2014

    • 30 Jun 2014 Z-2123-2014 Class II Terminated 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. Submission number: K062963

Frequently asked questions

How many devices does Ra Medical Systems, Inc have in the registry?

The registry currently lists 4 devices for Ra Medical Systems, Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ra Medical Systems, Inc's devices?

Among its 4 most recently registered devices, Ra Medical Systems, Inc has devices listed in FDA 510(k) (4 devices).

What risk classes do Ra Medical Systems, Inc's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Ra Medical Systems, Inc's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Ra Medical Systems, Inc?

FDA recall records list 7 recalls initiated by Ra Medical Systems, Inc, the most recent initiated on 16 Oct 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Ra Medical Systems, Inc in the registry?

The most recently registered devices listed for Ra Medical Systems, Inc include PHAROS EXCIMER LASER SYSTEM, MODEL EX-308, DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101), RA-308 Excimer Laser System, Excimer Laser Catheter and DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0).

Generated automatically from registry data and not verified by a human reviewer.