Recall Z-1825-2023— Remote Diagnostic Technologies Ltd.

Name: FDA recall Z-1825-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-08

Class II · Ongoing

Class II FDA medical device recall by Remote Diagnostic Technologies Ltd., initiated 2023-05-08. It names one FDA 510(k) clearance: K200849. Product: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020. Reason: Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM"..

Recalling firm: Remote Diagnostic Technologies Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-08
Firm location: Farnborough, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K200849 — Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company·cleared 2020-07-24

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

Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020

Reason for recall

Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".

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