Tempus LS — Class II medical device recall Z-0564-2021
Terminated recall by Remote Diagnostic Technologies Ltd., reported 2020-12-23, distributed nationwide. A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back
| Recall number | Z-0564-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Basingstoke, N/A, United Kingdom |
| Recall initiated | 2020-11-17 |
| Classified | 2020-12-11 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2023-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 175 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07613365002737 |
| Serial numbers | 7022-000137LS, 7022-000138LS, 7022-000139LS, 7022-000158LS, 7022.000102LS, 7022.000103LS, 7022.000105LS, 7022.000106LS, 7022.000108LS, 7022.000109LS, 7022.000110LS, 7022.000111LS, 7022.000112LS, 7022.000113LS, 7022.000114LS, 7022.000115LS, 7022.000116LS, 7022.000117LS, 7022.000119LS, 7022.000120LS, 7022.000121LS, 7022.000122LS, 7022.000123LS, 7022.000124LS, 7022.000125LS and 145 more |
| Model numbers | 00-3020 |
Product
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
Reason for recall
A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.
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-0564-2021. 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.