# FDA recall Z-1997-2021

> **Remote Diagnostic Technologies Ltd.** · Class II · device recall initiated 2021-05-25.

## Product

Tempus Pro - Patient  physiological monitor, arrhythmia detector and alarm.  Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

## Reason for recall

The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK.

## Key facts

- **Recall number:** Z-1997-2021
- **Recalling firm:** Remote Diagnostic Technologies Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-25
- **Report date:** 2021-07-07

- **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-1997-2021

## Citation

> AI Analytics. FDA recall Z-1997-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1997-2021. Source: US FDA. Licensed CC0.

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