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Terminated

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

FDA Recall Z-2076-2019 · Posted None

Recalling FirmLABORIE MEDICAL TECHNOLOGIES, CORP
Recall StatusTerminated
Product CodeFEN
Date Initiated2019-07-17
Date Terminated2023-07-10
Product Quantity2 US

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

Firm Action

Laborie issued letter via FedX on July 17, 2019 advising of the problem, health risk, and action to take: Quarantine the product and unplug the power supply from the wall socket until a replacement is provided. A new power supply unit(s) will be provided along with instructions on how to replace the power supplie in the field. Contact Laborie/MMS customer care with any questions, concerns or problems: Laborie MMS Customer Care Address: 400 Avenue D, Suite 10, Williston, VT 05495 Phone Number: 800.522.6743 Email: [email protected]

Root Cause

Nonconforming Material/Component

Distribution Pattern

US distribution in AZ, and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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