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).
Check against the official notice below — it lists the full affected range.
Remote Diagnostic Technologies Ltd. is recalling 175 Tempus LS manual defibrillators (Model 00-3020, Software Version 1.3.4) distributed nationwide in the United States. A software error has been identified that causes the ECG calibration to become inaccurate when the device exits pacer mode back into manual mode. This calibration error may result in delayed therapy because clinicians would not have an accurate ECG waveform to use when deciding whether a shock is needed. However, the device retains the ability to deliver a manual defibrillation shock.
The recall affects devices with specific serial numbers beginning with "LS 7022" and can be identified by UDI 07613365002737 and reference number 00-3020 with software version 1.3.4. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution. Quantity: 175 devices Lot/code info: 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 7022.000160 LS 7022.000192 LS 7022.000191 LS 7022.000261 LS 7022.000262 LS 7022.000263 LS 7022.000213 LS 7022.000212 LS 7022.000211 LS 7022.000199 LS 7022.000197 LS 7022.000200 LS 7022.000193 LS 7022.000194 LS 7022.000198 LS 7022.000195 LS 7022.000206 LS 7022.000207 LS 7022.000208 LS 7022.000112 LS 7022.00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.