RecallRadar

FDA Device recall Z-2076-2019

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

On 2019-07-31 the FDA classified a Class II recall of U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions by Laborie Medical Technologies, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2076-2019
ClassificationClass II
Statusterminated
Initiated2019-07-17
Published2019-07-31
Last updated2026-09-13 11:55 UTC
CompanyLaborie Medical Technologies
DistributionAZ, PA

Product

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

Reason

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

Identifiers

code_infoSerial Numbers: PE18-7SBL1452, PE18-7SBL 1414

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2076-2019%22

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