FDA Device recall Z-2076-2019
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions by Laborie Medical Technologies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2076-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-17 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Laborie Medical Technologies |
| Distribution | AZ, PA |
Product
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
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
Identifiers
| code_info | Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2076-2019%22
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