Recall Z-1997-2021— Remote Diagnostic Technologies Ltd.

Name: FDA recall Z-1997-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-25

Class II · Ongoing

Class II FDA medical device recall by Remote Diagnostic Technologies Ltd., initiated 2021-05-25. It names one FDA 510(k) clearance: K201746. Product: Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).. Reason: The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged..

Recalling firm: Remote Diagnostic Technologies Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2021-05-25
Firm location: Basingstoke, N/A, 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 physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

Reason for recall

The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.

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