Company: Remote Diagnostic Technologies Ltd.
Date of Enforcement Report: 12/23/2020
Class II
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).
Recall Number: Z-0564-2021
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/MANUFACTURER
Remote Diagnostic Technologies Ltd. on 11/17/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
175 devices
DISTRIBUTION
U.S. Nationwide