Recall Z-1321-2023— Remote Diagnostic Technologies Ltd.

Name: FDA recall Z-1321-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-23

Class II · Ongoing

Class II FDA medical device recall by Remote Diagnostic Technologies Ltd., initiated 2023-02-23. It names one FDA 510(k) clearance: K201746. 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 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..

Recalling firm: Remote Diagnostic Technologies Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-23
Firm location: Farnborough, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K201746 — Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited·cleared 2020-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

Data sourced from openFDA. This site is unofficial and independent of the FDA.