FDA Recalls Tempus LS Manual Defibrillators Due to Software Error
Remote Diagnostic Technologies is recalling 175 Tempus LS manual defibrillators because a software error may delay therapy by disrupting ECG calibration.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (delay in therapy) for a critical medical device, though no injuries or deaths are reported in the source text.
Plain-English summary
Remote Diagnostic Technologies Ltd. is recalling 175 units of the Tempus LS Manual Defibrillator (Model 00-3020, Software Version 1.3.4). The devices were distributed nationwide in the United States and are intended for pre-hospital care and transport applications, including ambulances and aircraft.
The recall is due to a software error detected in version 1.3.4. When exiting pacer mode and returning to manual mode, the pacer pulse wave may cause the ECG calibration to become inaccurate. This error may result in a delay in therapy because the clinician is not provided with an ECG waveform necessary to make a shockable rhythm decision. The device remains capable of delivering a manual defibrillation shock.
Healthcare providers and users should check their device serial numbers against the list provided in the official recall notice. If a device is affected, users should follow the instructions provided by the manufacturer or the FDA for remediation.
The recalled product
- Product
- Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Category
- Medical Device — Defibrillator
- Affected units
- 175
Distribution
Distributed nationwide across the United States.
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