Carlsbad, CA, United States
Ra Medical Systems, Inc. recalls
6 recalls recorded since 2018, most recently on 16 October 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 October 2020
- Terminated
- 11 January 2023
- Reason
- 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: Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0569-2021
- 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 lo
Terminated Class II Medical devices
- Recall started
- 24 July 2020
- Terminated
- 9 August 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 23 January 2020
- Terminated
- 1 November 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 19 September 2019
- Terminated
- 31 July 2023
- Reason
- 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, NV, MS, NE, MD, IL, OK, MA, WA, MO, WI, KY. OUS - Netherlands, Pakistan, United Kingdom, Italy, France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2006-2020
- 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: Produc
Terminated Class II Medical devices
- Recall started
- 23 August 2019
- Terminated
- 5 May 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1631-2020
- 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 l
Terminated Class II Medical devices
- Recall started
- 15 February 2018
- Reason
- Lasers/Catheters did not calibrate during set-up prior to use.
- Distribution
- U.S: CA, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2218-2019
- 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 con
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.