FDA Device recall Z-0564-2021

Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the f…

FDA Device
Class II
terminated
Published 2020-12-23

On 2020-12-23 the FDA classified a Class II recall of Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the f… by Remote Diagnostic Technologies, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0564-2021
Classification	Class II
Status	terminated
Initiated	2020-11-17
Published	2020-12-23
Last updated	2026-09-13 11:55 UTC
Company	Remote Diagnostic Technologies
Distribution	US

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).

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.

Identifiers

code_info	UDI: 07613365002737 REF: 00-3020 Software Version Number: 1.3.4 Serial Numbers: LS 7022.000218 LS 7022.000219 L… 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

code_info

UDI: 07613365002737 REF: 00-3020 Software Version Number: 1.3.4 Serial Numbers: LS 7022.000218 LS 7022.000219 L…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0564-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.