Class II — Remote Diagnostic Technologies Ltd.
| Recalling firm | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
|---|---|
| Registered facility | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Distribution of Defibrillators that are not approved or cleared for distribution US Market. |
| Product | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of IL and KS. |
| Initiated | 2022-01-28 |
| Classified | 2022-04-04 |
| Terminated | 2024-07-25 |
| Recall number | Z-0861-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Remote Diagnostic Technologies Ltd. (Z-0861-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89595/
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