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Recall Observatory FDA recall evidence

Device product

Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020

Z-1825-2023

May 08, 2023

Class II

Product summary

Firm
Remote Diagnostic Technologies Ltd.
Event
Event 92251
Status
Ongoing
Classification
Class II
Quantity
1147
Official record key
device-enforcement:Z-1825-2023

Official wording

Reason: Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".

Code information: UDI-DI: 07613365002737. Serial numbers prior to 7022.001634

Distribution pattern: US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".