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U.S. Department of Health and Human Services

Class 2 Device Recall Solar Blue

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  Class 2 Device Recall Solar Blue see related information
Date Initiated by Firm July 17, 2019
Create Date July 25, 2019
Recall Status1 Terminated 3 on July 10, 2023
Recall Number Z-2076-2019
Recall Event ID 83310
Product Classification Device, cystometric, hydraulic - Product Code FEN
Product U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Code Information Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414
Recalling Firm/
Manufacturer		 LABORIE MEDICAL TECHNOLOGIES, CORP
400 Avenue D Ste 10
Williston VT 05495-7828
For Additional Information Contact SAME
914-735-8600
Manufacturer 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
FDA Determined
Cause 2		 Nonconforming Material/Component
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: customercareusa@laborie.com
Quantity in Commerce 2 US
Distribution US distribution in AZ, and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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