The Recall Desk
ModerateFDA (Devices)·Z-1666-2025·Announced 2025-04-30

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.

What this means for you

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 Only)],
Manufacturer
Remote Diagnostic Technologies Ltd.
Category
Medical Device — Patient Monitor
Hazard
  • software-error
  • device-malfunction

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

Distributed nationwide across the United States.

Related recalls

Same category