U3-3 Solar Blue recalled over fire hazard

Recall date

July 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LABORIE MEDICAL TECHNOLOGIES, CORP recalls U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract…

Recall number

Z-2076-2019

FDA classification

Class II

Brand / firm

LABORIE MEDICAL TECHNOLOGIES, CORP

Sold / distributed

US distribution in AZ, and PA.

Why it was recalled

Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions