# FDA recall Z-1321-2023

> **Remote Diagnostic Technologies Ltd.** · Class II · device recall initiated 2023-02-23.

## Product

Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.    The affected power supplies are related to the following Tempus Pro Patient Monitoring units:    Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R  Model Numbers:  00-1004  00-1004-R  00-1007  00-1007-R  00-1024-R  00-1026-R

## Reason for recall

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

## Distribution

Worldwide Distribution: U.S.(nationwide): AL, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and O.U.S.(foreign): United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Brunei Darussalam, Bolivia, Canada, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Cayman Islands, Luxembourg, Malaysia, Netherlands, Norway, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Mayotte, and South Africa.

## Key facts

- **Recall number:** Z-1321-2023
- **Recalling firm:** Remote Diagnostic Technologies Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-23
- **Report date:** 2023-04-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2023

## Citation

> AI Analytics. FDA recall Z-1321-2023. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/Z-1321-2023. Source: US FDA. Licensed CC0.

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