Recall Z-0861-2022— Remote Diagnostic Technologies Ltd.

Name: FDA recall Z-0861-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-28

Class II · Terminated

Class II FDA medical device recall by Remote Diagnostic Technologies Ltd., initiated 2022-01-28, terminated 2024-07-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693. Reason: Distribution of Defibrillators that are not approved or cleared for distribution US Market..

Recalling firm: Remote Diagnostic Technologies Ltd.
Classification: Class II
Status: Terminated
Initiated: 2022-01-28
Terminated: 2024-07-25
Firm location: Basingstoke, United Kingdom

Product description

Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693

Reason for recall

Distribution of Defibrillators that are not approved or cleared for distribution US Market.

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