Tempus LS — Class II medical device recall Z-0861-2022
Terminated recall by Remote Diagnostic Technologies Ltd., reported 2022-04-13, distributed nationwide. Distribution of Defibrillators that are not approved or cleared for distribution US Market.
| Recall number | Z-0861-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Basingstoke, United Kingdom |
| Recall initiated | 2022-01-28 |
| Classified | 2022-04-04 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 07613365001693 |
| Serial numbers | 7021.002073, 7021.002074 |
| Model numbers | 00-3010, 3.940590 |
Product
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Reason for recall
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
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-0861-2022. 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.