Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is… — Class III medical device recall Z-0557-2025
Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2024-12-04, distributed nationwide. Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT
| Recall number | Z-0557-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Farnborough, United Kingdom |
| Recall initiated | 2024-10-28 |
| Classified | 2024-11-26 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613365002737 |
| Serial numbers | 7022.000367, 7022.000387, 7022.000392, 7022.000462, 7022.000463, 7022.000464, 7022.000559, 7022.000591, 7022.000595, 7022.000711, 7022.000781, 7022.000786, 7022.00108, 7022.001175, 7022.001201, 7022.00129, 7022.001556, 7022.001582 |
| Model numbers | 00-3020 |
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
Reason for recall
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
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-0557-2025. 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.