Recall Z-2076-2019 ยท FEN Device, Cystometric, Hydraulic
LABORIE MEDICAL TECHNOLOGIES, CORP
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
| Date | Jul 17, 2019 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 2 US |
| Distribution | US distribution in AZ, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.