FDAClass IIJuly 31, 2019

U3-3 Solar Blue recall

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

Why was U3-3 Solar Blue 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Recalling firm
LABORIE MEDICAL TECHNOLOGIES, CORP
Quantity
2 US
Distribution
US distribution in AZ, and PA.
Recall date
July 31, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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