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
Z-0557-2025
Product summary
- Event
- Event 95642
- Status
- Ongoing
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0557-2025
Official wording
Reason: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Code information: 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
Distribution pattern: U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.
Derived failure modes
-
Labeling or packaging
incorrect labels