FDAFDA · Food and drugs·Recall number Z-0557-2025
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Published December 4, 2024 · Recall initiated: October 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Distributor
- U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.
- Lot
- Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United Kingdom
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