Recall Z-0557-2025— Remote Diagnostic Technologies Ltd.

Name: FDA recall Z-0557-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-28

Class III · Ongoing

Class III FDA medical device recall by Remote Diagnostic Technologies Ltd., initiated 2024-10-28. It names one FDA 510(k) clearance: K200849. Product: Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode. Reason: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number..

Recalling firm: Remote Diagnostic Technologies Ltd.
Classification: Class III
Status: Ongoing
Initiated: 2024-10-28
Firm location: Farnborough, 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

Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

Reason for recall

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

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