FDA recall Z-0557-2025

Remote Diagnostic Technologies Ltd. · Class III · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-10-28
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Farnborough, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0557-2025