| Z-0557-2025 |
Tempus LS-Manual Defibrillator Model 00-3020
The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Reason: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
|
2024-10-28 |
Open, Classified
|
View Details
|
| Z-1027-2026 |
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R.
USB 2-Channel IBP Module, REF: 01-2017.
Used with User/Operator Manual
Reason: Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
|
2025-11-26 |
Open, Classified
|
View Details
|
| Z-1321-2023 |
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications.
The affected power supplies are related to the following Tempus Pro Patient Monitoring units:
Model Numbers:
00-1004
00-1004-R
00-1007
00-1007-R
00-1024-R
00-1026-R
Model Numbers:
00-1004
00-1004-R
00-1007
00-1007-R
00-1024-R
00-1026-R
Reason: During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
|
2023-02-23 |
Open, Classified
|
View Details
|
| Z-1666-2025 |
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Reason: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
|
2025-04-16 |
Open, Classified
|
View Details
|
| Z-1729-2025 |
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R,
00-1026-R, 00-1004, 00-1007
Reason: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
|
2025-04-15 |
Open, Classified
|
View Details
|
| Z-1825-2023 |
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Reason: Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard
to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
|
2023-05-08 |
Open, Classified
|
View Details
|
| Z-2028-2024 |
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Reason: Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
|
2024-05-09 |
Open, Classified
|
View Details
|
| Z-2175-2025 |
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
Reason: Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
|
2025-05-30 |
Open, Classified
|
View Details
|
| Z-2625-2023 |
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
Reason: Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.
|
2023-08-24 |
Open, Classified
|
View Details
|