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