FDA recall Z-2076-2019

Product

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

Reason for recall

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

Distribution

US distribution in AZ, and PA.

Key facts

Status

Terminated

Initiation date

2019-07-17

Report date

2019-07-31

Termination date

2023-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Williston, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2076-2019