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Ra Medical Systems Recalls
7 recalls on record · August 6, 2014 to December 23, 2020 · Medical Devices
Recalls by year
14
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 23, 2020Medical DevicesFDA
Ra Medical Systems, Inc. recalls DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disea
Hazard: 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.
October 14, 2020Medical DevicesFDA
Ra Medical Systems, Inc. recalls DABRA RA-308 Excimer Laser, SN: ******* - Product Usage: The device is intended for use in ablating a channel in occlusi
Hazard: Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.
July 15, 2020Medical DevicesFDA
Ra Medical Systems, Inc. recalls DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and
Hazard: 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.
May 20, 2020Medical DevicesFDA
Ra Medical Systems, Inc. recalls Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-
Hazard: 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.
April 8, 2020Medical DevicesFDA
Ra Medical Systems, Inc. recalls Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the ski
Hazard: 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.
August 14, 2019Medical DevicesFDA
Ra Medical Systems Inc recalls The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occl
Hazard: Lasers/Catheters did not calibrate during set-up prior to use.
August 6, 2014Medical DevicesFDA
Ra Medical Systems Inc recalls PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis a
Hazard: 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.