FDA Enforcement
Class II
Ongoing
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Recall: Z-1825-2023
·
Reported June 21, 2023
Enforcement
- Recall Number
- Z-1825-2023
- Event ID
- 92251
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Remote Diagnostic Technologies Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 21, 2023
- Initiation Date
- May 8, 2023
- Classification Date
- June 12, 2023
- Address
- Farnborough Aerospace Centre, Aerospace Boulevard, Farnborough, N/A, N/A, United Kingdom
Description
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
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 Info
UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
Distribution
US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
Quantity
1147