The FDA announced on May 9, 2024, that Remote Diagnostic Technologies Ltd. is recalling Philips Tempus LS-Manual Defibrillators with Part Number 00-3020 due to potential ECG signal distortions. The recall affects units with serial numbers prior to 7022.002871 when used with specific user manuals.
How to tell if you have it
- Brand: Philips
- Product: Tempus LS-Manual Defibrillator
- Part Number: 00-3020
- UDI-DI: 07613365002737
- Serial Numbers: prior to 7022.002871
- Manual Versions: 41-3007EN-01 and prior
The hazard
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference. This interference may lead to distortions of the ECG signal, which could result in no or ineffective pacing, or no or inappropriate defibrillation pulse.
Context
GovInfoNow's records show Remote Diagnostic Technologies Ltd. has 11 other recalls on record since November 17, 2020. Recent brand recalls include a patient monitor measuring Intracranial Pressure and Bladder Pressure without validation (November 26, 2025), an Inseego USB8 4G Dongle Kit with outdated software (May 30, 2025), and a Tempus Pro Patient Monitor software error (April 16, 2025). Other recent recalls of similar products include the Philips Cardiac Workstation 7000 and 5000 inaccurate heart rate data risks (July 1, 2026) and the Philips Allura Xper FD10C Medical System electrical short-circuit risk (December 15, 2025).