Z-1825-2023 Class II Ongoing

Recalled by Remote Diagnostic Technologies Ltd. — Farnborough, N/A

Recall Details

Product Type
Devices
Report Date
June 21, 2023
Initiation Date
May 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1147

Product Description

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

Reason for Recall

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".

Distribution Pattern

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

Code Information

UDI-DI: 07613365002737. Serial numbers prior to 7022.001634