FDA-Device2020-12-23Class II
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).
Remote Diagnostic Technologies Ltd.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
175 devices
Manufactured in
PAVILION C2, ASHWOOD PARK, ASHWOOD WAY, Basingstoke, N/A, United Kingdom
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2021Don't want to check this manually?
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