Tempus Pro Patient Monitor software error when using video laryngoscope
Remote Diagnostic Technologies Ltd. is recalling Tempus Pro Patient Monitors due to a software issue that causes an error screen when a video laryngoscope is attached to the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a software error that causes a functional malfunction during operation, which represents a potential operational risk but does not meet the criteria for High severity (which requires reported injury, high-risk pathogens, or allergen mislabeling on common allergens).
Plain-English summary
Remote Diagnostic Technologies Ltd. is recalling multiple models of the Tempus Pro Patient Monitor, including non-printer and printer versions with various configurations (REFs: 00-1004-R, 00-1007-R, 00-1007, 00-1024-R, 00-1026-R, and 00-1004). The recall affects approximately 6,961 units distributed worldwide, including throughout the United States and internationally.
The monitors are subject to recall due to a software issue that causes an error screen to appear on the portable vital signs monitor when a video laryngoscope is attached. This malfunction could interfere with the device's normal operation during critical patient monitoring.
The recalled units were distributed nationwide across all U.S. states and to multiple countries including the United Kingdom, Canada, Australia, and others. Patients and healthcare facilities using affected Tempus Pro monitors should immediately contact Remote Diagnostic Technologies Ltd. for guidance on the software correction or device replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Category
- Medical Device — Patient Monitor
- Affected units
- 6,961
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- All Lots/ UDI-DI(s): 00-1004-R - 05060472440020 & 05060472442901
- 00-1007-R - 05060472440013 & 05060472442918
- 00-1024-R - 05060472441027 & 05060472442925
- 00-1026-R - 05060472441058 & 05060472442932
- 00-1004 - 05060472440624
- 00-1007 - 05060472440655
Distribution
Related recalls
Same manufacturer · Remote Diagnostic Technologies Ltd.
See all →- HighPatient monitors recalled over unvalidated intracranial and bladder pressure measurements
FDA (Devices) · 2026-01-14
- HighInseego dongle kit flash drives carry outdated patient monitor software
FDA (Devices) · 2025-08-06
- ModeratePhilips Tempus Pro Patient Monitor Software Update for Operational Issues
FDA (Devices) · 2025-05-14
- LowTempus LS-Manual Defibrillator Recalled for Incorrect Servicing Labels
FDA (Devices) · 2024-12-04
- HighPhilips Tempus LS-Manual Defibrillator may malfunction from electrical interference
FDA (Devices) · 2024-06-12
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- HighTempus Pro Patient Monitor Software Error Risk When Unplugged
FDA (Devices) · 2021-07-07
- HighPhilips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring
FDA (Devices) · 2023-09-27
- HighPatient monitors recalled over unvalidated intracranial and bladder pressure measurements
FDA (Devices) · 2026-01-14
- HighTempus Pro Patient Monitor power supplies recalled for fluid ingress and safety issues
FDA (Devices) · 2023-04-12
- ModeratePhilips Tempus Pro Patient Monitor Software Update for Operational Issues
FDA (Devices) · 2025-05-14
- HighFDA Recalls Tempus LS Manual Defibrillators Due to Software Error
FDA (Devices) · 2020-12-23