| Date Initiated by Firm |
November 17, 2020 |
| Date Posted |
December 11, 2020 |
| Recall Status1 |
Terminated 3 on December 12, 2023 |
| Recall Number |
Z-0564-2021 |
| Recall Event ID |
86801 |
| 510(K)Number |
K200849
|
| Product Classification |
Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
|
| 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). |
| Code Information |
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 7022.000113 LS 7022.000264 LS 7022.000266 LS 7022.000267 LS 7022.000268 LS 7022.000269 LS 7022.000270 LS 7022.000271 LS 7022.000272 LS 7022.000273 LS 7022.000274 LS 7022.000227 LS 7022.000228 LS 7022.000229 LS 7022.000230 LS 7022.000231 LS 7022.000232 LS 7022.000236 LS 7022.000237 LS 7022.000238 LS 7022.000239 LS 7022.000161 LS 7022.000162 LS 7022.000163 LS 7022.000164 LS 7022.000165 LS 7022.000166 LS 7022.000167 LS 7022.000168 LS 7022.000169 LS 7022.000170 LS 7022-000158 LS 7022.000103 LS 7022.000133 LS 7022.000134 LS 7022.000136 LS 7022.000144 LS 7022.000148 LS 7022.000149 LS 7022-000137 LS 7022.000153 LS 7022.000181 LS 7022.000180 LS 7022.000182 LS 7022.000185 LS 7022.000184 LS 7022.000183 LS 7022.000220 LS 7022.000147 LS 7022.000146 LS 7022.000130 LS 7022.000131 LS 7022.000132 LS 7022.000135 LS 7022.000159 LS 7022.000243 LS 7022.000244 LS 7022.000245 LS 7022.000242 LS 7022.000241 LS 7022.000102 LS 7022.000105 LS 7022.000106 LS 7022.000108 LS 7022.000109 LS 7022.000114 LS 7022.000115 LS 7022.000116 LS 7022.000117 LS 7022.000119 LS 7022.000120 LS 7022.000121 LS 7022.000122 LS 7022.000123 LS 7022.000124 LS 7022.000125 LS 7022.000126 LS 7022.000127 LS 7022.000128 LS 7022.000129 LS 7022.000151 |
Recalling Firm/
Manufacturer |
Remote Diagnostic Technologies Ltd.
PAVILION C2, ASHWOOD PARK
ASHWOOD WAY
Basingstoke United Kingdom
|
Manufacturer 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 2 |
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 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. |
| Quantity in Commerce |
175 devices |
| Distribution |
US Nationwide distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = LDD and Original Applicant = Remote Diagnostic Technologies, Ltd, a Philips Company
|
