# FDA recall Z-2028-2024

> **Remote Diagnostic Technologies Ltd.** · Class II · device recall initiated 2024-05-09.

## Product

Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

## Reason for recall

Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

## Distribution

US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.

## Key facts

- **Recall number:** Z-2028-2024
- **Recalling firm:** Remote Diagnostic Technologies Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-09
- **Report date:** 2024-06-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2028-2024

## Citation

> AI Analytics. FDA recall Z-2028-2024. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/Z-2028-2024. Source: US FDA. Licensed CC0.

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