FDA Device recall Z-0557-2025
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
- FDA Device
- Class III
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class III recall of Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode by Remote Diagnostic Technologies, citing due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0557-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-10-28 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Remote Diagnostic Technologies |
| Distribution | US |
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
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Identifiers
| code_info | Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.…Model Number: 00-3020 UDI-DI code: 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0557-2025%22
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