FDA Device

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

Hazard

Lasers/Catheters did not calibrate during set-up prior to use.

What You Should Do

Remedy

On 02/15/18, service technicians started visiting customer facilities to service affected lasers.

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Products

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-cont
Brand
Ra Medical Systems Inc
UPC
Serial Numbers: 0016, 0039, 0044, 0048

Units Affected

4

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