Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Recall Initiated
- May 8, 2023
- Posted
- June 12, 2023
- Recall Number
- Z-1825-2023
- Quantity
- 1147
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.
Lot / Code Info
UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
Root Cause
Device Design
Action Taken
On 5/8/23, Philips mailed correction notices to customers who were asked to do the following: Potential risks associated with partial or complete failure of the device, should a patient be involved, will be mitigated by immediately starting CPR/ chest compressions in case of device dysfunction/failure. Philips will contact to arrange for the device to be returned for rework. A loner device will be provided during the time of the rework. This notice needs to be shared with those who need to be aware within your organization and any organization where the potentially affected devices have been transferred. Complete and return the Customer/Distributor Reply Form: https://philips.efmfeedback.com/se/705E3ED8496AFDF8/ https://philips.efmfeedback.com/se/705E3ED8496AFDF8 Customers/Distributors who need further information or support can contact RDT.Recall.Response@Philips.com, or 1 800 722 9377 In addition, distributors were asked to forward the correction notice to their customers. The notice should be modified to include the distributor's contact information.