Recall Z-2076-2019
Laborie Medical Technologies, Corp · initiated July 17, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Codes / lots: Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414
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: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-2076-2019
- Initiated
- July 17, 2019
- Terminated
- July 10, 2023
- Product code
- FEN – Device, Cystometric, Hydraulic
- Quantity
- 2 US
- Distribution
- US distribution in AZ, and PA.
- Recalling firm
- Laborie Medical Technologies, Corp, Williston, VT