LABORIE MEDICAL TECHNOLOGIES, CORP: Medical Device Recall in 2019 - (Recall #: Z-2076-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.
Product Description:

U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions

Product Classification:

Class II

Date Initiated: July 17, 2019
Date Posted: July 31, 2019
Recall Number: Z-2076-2019
Event ID: 83310
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

Status: Terminated
Product Quantity: 2 US
Code Information:

Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414

Distribution Pattern:

US distribution in AZ, and PA.

Voluntary or Mandated:

Voluntary: Firm initiated