Z-1825-2023 Class II Ongoing
FDA device recall Z-1825-2023 was initiated by Remote Diagnostic Technologies Ltd. on May 8, 2023 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 1147.
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