LABORIE MEDICAL TECHNOLOGIES, CORP U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Brand
LABORIE MEDICAL TECHNOLOGIES, CORP
Lot Codes / Batch Numbers
Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414
Products Sold
Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414
LABORIE MEDICAL TECHNOLOGIES, CORP is recalling U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing l due to Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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: customercareusa@laborie.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, IN, PA
Page updated: Jan 10, 2026