FDA-Device2019-07-31Class II
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
LABORIE MEDICAL TECHNOLOGIES, CORP
Hazard
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
Sold states
US distribution in AZ, and PA.
Affected count
2 US
Manufactured in
400 Avenue D Ste 10, N/A, Williston, VT, United States
Products
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2076-2019Don't want to check this manually?
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