Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended

FDA device recall Z-0564-2021 · posted 2020-12-11 · Terminated

Recall details

Recalling firm

Remote Diagnostic Technologies Ltd.

Reason for recall

A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.

Action taken

Customers are asked to follow the "Action to be Taken by Customer/User" section of the recall notice which states the following : The device continues to be able to deliver defibrillation therapy if this fault condition occurs. The problem is resolved by: - Manually exiting Pacer mode into Manual defibrillation mode, and then must power cycle the device by: - Holding the power button to turn the device off and then power on again using the power button. The device will restart in the default manual defibrillation mode. Alternatively, switching to a different Defibrillator may be used to monitor ECG waveform and perform a defibrillation shock. Please complete the attached reply card, so that RDT may provide the USB Flash Drive to the correct location and recipient to upgrade your device/s. Once you receive the USB Flash Drive, follow the instructions to upgrade the device/s.

Root cause

Software design

Status

Terminated

Product code

LDD

Quantity affected

175 devices

Distribution

US Nationwide distribution.

Date initiated

2020-11-17

Date posted

2020-12-11

Date terminated

2023-12-12

Location

Basingstoke, United Kingdom

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