Recall Z-0564-2021
Remote Diagnostic Technologies Ltd. · initiated November 17, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: UDI: 07613365002737 REF: 00-3020 Software Version Number: 1.3.4 Serial Numbers: LS 7022.000218 LS 7022.000219 LS 7022.000221 LS 7022.000222 LS 7022.000223 LS 7022.000224 LS 7022.000201 LS 7022.000202 LS 7022.000203 LS 7022.000204 LS 7022.000225 LS 7022.000226 LS 7022.000214 LS 7022.000215 LS 7022.000216 LS 7022.000217 LS 7022.000150 LS 7022.000190 LS 7022.000189 LS 7022.000186 LS 7022.000188 LS 7022.000187 LS 7022.000186 LS 7022.000187 LS 7022.000188 LS 7022.000189 LS 7022.000190 LS 7022.000209 LS 7022.000143 LS 7022.000141 LS 7022.000276 LS 7022.000265 LS 7022.000110 LS 7022.000111 LS 7022.000152 LS 7022.000171 LS 7022.000172 LS 7022.000173 LS 7022.000174 LS 7022.000175 LS 7022.000176 LS 7022.000177 LS 7022.000178 LS 7022.000205 LS 7022.000156 LS 7022.000281 LS 7022.000234 LS 7022.000283 LS 7022.000247 LS 7022.000235 LS 7022.000260 LS 7022.000255 LS 7022.000246 LS 7022.000249 LS 7022.000284 LS 7022.000282 LS 7022.000251 LS 7022.000233 LS 7022.000250 LS 7022.000257 LS 7022.000248 LS 7022.000254 LS 7022.000256 LS 7022.000252 LS 7022.000258 LS 7022.000179 LS 7022.000142 LS 7022.000145 LS 7022.000154 LS 7022.000155 LS 7022-000139 LS 7022-000138 LS 7022.000140 LS 7022.000157 LS…
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.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-0564-2021
- Initiated
- November 17, 2020
- Posted by FDA
- December 11, 2020
- Terminated
- December 12, 2023
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Quantity
- 175 devices
- Distribution
- US Nationwide distribution.
- Recalling firm
- Remote Diagnostic Technologies Ltd., Basingstoke