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

[pending] Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00

Pending LLM rewrite. Source: FDA_DEVICE Z-1666-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

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 — Devices

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