Z-2076-2019 Class II Terminated
FDA device recall Z-2076-2019 was initiated by LABORIE MEDICAL TECHNOLOGIES, CORP on July 17, 2019 and is designated Class II. 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 haz… The recall status is terminated (terminated July 10, 2023). Affected quantity: 2 US.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- July 17, 2019
- Termination Date
- July 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 US
Product Description
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
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
Distribution Pattern
US distribution in AZ, and PA.
Code Information
Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414