Remote Diagnostic Technologies product recalled over labeling errors

Recall date

October 28, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Remote Diagnostic Technologies Ltd. recalls Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual…

Recall number

Z-0557-2025

FDA classification

Class III

Brand / firm

Remote Diagnostic Technologies Ltd.

Sold / distributed

U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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