Recall Z-0564-2021— Remote Diagnostic Technologies Ltd.

Name: FDA recall Z-0564-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-17

Class II · Terminated

Class II FDA medical device recall by Remote Diagnostic Technologies Ltd., initiated 2020-11-17, terminated 2023-12-12. It names one FDA 510(k) clearance: K200849. 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).. Reason: 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..

Recalling firm: Remote Diagnostic Technologies Ltd.
Classification: Class II
Status: Terminated
Initiated: 2020-11-17
Terminated: 2023-12-12
Firm location: Basingstoke, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K200849 — Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company·cleared 2020-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.