U3-3 Solar Blue — Class II medical device recall Z-2076-2019
Terminated recall by LABORIE MEDICAL TECHNOLOGIES, CORP, reported 2019-07-31, distributed in AZ, PA. Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does
| Recall number | Z-2076-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LABORIE MEDICAL TECHNOLOGIES, CORP, Williston, VT, United States |
| Recall initiated | 2019-07-17 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2023-07-10 |
| Distributed | AZ, PA |
| Quantity | 2 us |
| Reason classes | labeling |
| Serial numbers | 1414, PE18-7SBL, PE18-7SBL1452 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2076-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.