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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,745
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
Related recalls
Same manufacturer · Remote Diagnostic Technologies Ltd.
See all →- HighPatient monitors recalled over unvalidated intracranial and bladder pressure measurements
FDA (Devices) · 2026-01-14
- HighInseego dongle kit flash drives carry outdated patient monitor software
FDA (Devices) · 2025-08-06
- ModeratePhilips Tempus Pro Patient Monitor Software Update for Operational Issues
FDA (Devices) · 2025-05-14
- ModerateTempus Pro Patient Monitor software error when using video laryngoscope
FDA (Devices) · 2025-04-30
- LowTempus LS-Manual Defibrillator Recalled for Incorrect Servicing Labels
FDA (Devices) · 2024-12-04
Same hazard · electrical interference
See all →- HighNovaGuide 2 Ultrasound System Recall Due to Grounding Cable Disconnection Risk
FDA (Devices) · 2024-07-03
- HighNovaGuide 2 Ultrasound Systems Recalled for Electrical Shock Risk
FDA (Devices) · 2024-07-03
- SevereCereLink ICP Monitor recalled for out-of-range pressure readings
FDA (Devices) · 2022-08-03
- HighStryker S-Series Equipment Management System Recall for Brake Disengagement Risk
FDA (Devices) · 2021-03-31
- High
Similar recalls
- HighPhilips Tempus LS-Manual Defibrillator pacing failure due to communication error
FDA (Devices) · 2023-06-21
- HighFDA Recalls Tempus LS Manual Defibrillators Due to Software Error
FDA (Devices) · 2020-12-23
- LowTempus LS-Manual Defibrillator Recalled for Incorrect Servicing Labels
FDA (Devices) · 2024-12-04
- HighDefibrillator devices unapproved for US market recalled by FDA
FDA (Devices) · 2022-04-13
- HighPhilips HeartStart MRx Monitor/Defibrillator Recalled for ECG Cable Wear
FDA (Devices) · 2014-03-05
- HighPhilips HeartStart XL+ Defibrillator Recalled for Therapy Board Malfunction
FDA (Devices) · 2014-04-16