Ra Medical Systems Inc Recalls
Showing 1-2 of 2 recalls
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 light source contains a microprocessor with software to provide safety features and a user-friendly interface. The laser operates by producing a high current discharge within a chamber that is filled with rare gases and h
Lasers/Catheters did not calibrate during set-up prior to use.
On 02/15/18, service technicians started visiting customer facilities to service affected lasers.
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
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.
Ra Medical Systems sent a customer letter dated June 30, 2014, to who purchased the PHAROS EX-308 Excimer Laser Phototherapy System Hand Piece. The letter informed the customers of the problems identified and the actions to be taken. Customers were also provided with the Instructions for Use (IFU) for the PHAROS EX-308 Excimer Laser Phototherapy System Hand Piece and a replacement iris indication label for the handpiece.