Known Identifiers & Locations
FEI Numbers
3003832357
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| 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 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.
|
2020-11-17 |
Terminated
|
View Details
|
| Z-0861-2022 |
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Reason: Distribution of Defibrillators that are not approved or cleared for distribution US Market.
|
2022-01-28 |
Terminated
|
View Details
|
| Z-1997-2021 |
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm.
Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
Reason: The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
|
2021-05-25 |
Open, Classified
|
View Details
|
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