The Recall Desk
HighFDA (Devices)·Z-1321-2023·Announced 2023-04-12

Tempus Pro Patient Monitor power supplies recalled for fluid ingress and safety issues

Remote Diagnostic Technologies is recalling 5,540 Tempus Pro Patient Monitors due to fluid ingress and basic safety issues identified with power supplies during internal testing.

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: Class II medical device recall with identified fluid ingress and safety defects in power supplies. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High severity.

Plain-English summary

The Tempus Pro Patient Monitor is a portable vital signs monitor used by clinicians and medically qualified personnel in clinical and pre-hospital care settings to monitor single or multiple vital signs in attended or unattended situations.

Remote Diagnostic Technologies Ltd. is recalling 5,540 units (Models 00-1004, 00-1004-R, 00-1007, 00-1007-R, 00-1024-R, and 00-1026-R) due to fluid ingress and basic safety issues affecting the power supplies. These issues were identified during internal regulatory compliance testing.

The affected units were distributed worldwide, including throughout the United States and to numerous countries including Canada, the United Kingdom, Germany, France, Australia, and others.

Users of these monitors should contact Remote Diagnostic Technologies Ltd. for instructions regarding device replacement, repair, or continued safe use of the affected units.

The recalled product

Product
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 supp
Manufacturer
Remote Diagnostic Technologies Ltd.
Category
Medical Device — Patient Monitoring / Vital Signs Monitor
Hazard
Affected units
5,540

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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