Philips Tempus LS-Manual Defibrillator may malfunction from electrical interference
Simultaneous ECG measurements with multiple devices can cause electrical interference that may prevent this defibrillator from functioning properly. The recall affects 1,745 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential device malfunction (lack of defibrillation capability) caused by electrical interference—a theoretical but plausible risk in a critical medical device where failure could result in serious harm.
Plain-English summary
Remote Diagnostic Technologies Ltd. is recalling 1,745 units of the Philips Tempus LS-Manual Defibrillator (Part Number 00-3020) nationwide. The recall is due to a potential electrical interference issue that may occur when this defibrillator is used simultaneously with other ECG measurement devices on the same patient.
Electrical noise or interference from simultaneous ECG measurements can distort the ECG signal. This signal distortion may prevent the defibrillator from delivering an effective pacing or defibrillation pulse, or may cause it to deliver an inappropriate pulse. These malfunctions could compromise the device's ability to provide appropriate cardiac treatment.
The affected devices have serial numbers prior to 7022.002871 and use User/Operator Manual versions 41-3007EN-01 or earlier (UDI-DI-07613365002737). The devices were distributed throughout the United States.
The recalled product
- Product
- Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Category
- Medical Device — Defibrillator
- Hazard
- electrical-interference
- ecg-signal-distortion
- pacing-malfunction
- defibrillation-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 00-3020: UDI-DI-07613365002737
Distribution
Distributed nationwide across the United States.
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