# FDA recall Z-0564-2021

> **Remote Diagnostic Technologies Ltd.** · Class II · device recall initiated 2020-11-17.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0564-2021
- **Recalling firm:** Remote Diagnostic Technologies Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-17
- **Report date:** 2020-12-23
- **Termination date:** 2023-12-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Basingstoke, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2021

## Citation

> AI Analytics. FDA recall Z-0564-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0564-2021. Source: US FDA. Licensed CC0.

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