# FDA recall Z-0861-2022

> **Remote Diagnostic Technologies Ltd.** · Class II · device recall initiated 2022-01-28.

## Product

Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693

## Reason for recall

Distribution of Defibrillators that are not approved  or cleared for distribution US Market.

## Distribution

US Nationwide distribution in the states of IL and KS.

## Key facts

- **Recall number:** Z-0861-2022
- **Recalling firm:** Remote Diagnostic Technologies Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-28
- **Report date:** 2022-04-13
- **Termination date:** 2024-07-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2022

## Citation

> AI Analytics. FDA recall Z-0861-2022. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0861-2022. Source: US FDA. Licensed CC0.

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