Remote Diagnostic Technologies Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0861-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 28, 2022

Date Posted: April 13, 2022

Recall Number: Z-0861-2022

Event ID: 89595

Reason for Recall:

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

Status: Terminated

Product Quantity: 2

Code Information:

Device Serial Numbers 7021.002073 and 7021.002074

Distribution Pattern:

US Nationwide distribution in the states of IL and KS.

Voluntary or Mandated:

Voluntary: Firm initiated