FDA recall Z-1825-2023

Product

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

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

Key facts

Status

Ongoing

Initiation date

2023-05-08

Report date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Farnborough, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2023