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
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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
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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 |
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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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