FDAFDA · Food and drugs·Recall number Z-1825-2023
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Published June 21, 2023 · Recall initiated: May 8, 2023
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
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".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Distributor
- US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
- Lot
- UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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