Recall Z-0564-2021 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Remote Diagnostic Technologies Ltd.
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).
| Date | Dec 11, 2020 (initiated Nov 17, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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 us |
| Quantity | 175 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200849 | Tempus LS - Manual Remote Diagnostic Technologies, Ltd. A Philips Company, Jul 24, 2020 |