Recall – Uncleared defibrillator distributed

Company: Remote Diagnostic Technologies Ltd.
Date of Enforcement Report: 4/13/2022
Class II

PRODUCT

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

Recall Number:

Z-0861-2022

REASON

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

RECALLING FIRM/MANUFACTURER

Remote Diagnostic Technologies Ltd. on 1/28/2022. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

2

DISTRIBUTION

U.S. Nationwide

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.