Class III — Remote Diagnostic Technologies Ltd.
| Recalling firm | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
|---|---|
| Registered facility | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
| Product | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode |
| Distribution | U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA. |
| Initiated | 2024-10-28 |
| Classified | 2024-11-26 |
| Recall number | Z-0557-2025 |
| 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 III recall — Remote Diagnostic Technologies Ltd. (Z-0557-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95642/
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