Recall Z-1666-2025— Remote Diagnostic Technologies Ltd.

Name: FDA recall Z-1666-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-16

Class II · Ongoing

Class II FDA medical device recall by Remote Diagnostic Technologies Ltd., initiated 2025-04-16. It names 2 FDA 510(k) clearances: K201746, K130773. 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)], 00-1004 00-1004 [Tempus Pro (IB Only)]. Reason: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope..

Recalling firm: Remote Diagnostic Technologies Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-16
Firm location: Farnborough, N/A, United Kingdom

510(k) clearances named in this recall

2 on FDA's record

K201746 — Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited·cleared 2020-09-18
K130773 — TEMPUS PRO PATIENT MONITORRemote Diagnostic Technologies , Ltd.·cleared 2013-06-05

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, 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)], 00-1004 00-1004 [Tempus Pro (IB Only)]

Reason for recall

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

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