Recall Z-1825-2023 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
| Date | Jun 12, 2023 (initiated May 8, 2023) |
| Status | Open, Classified |
| 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". |
| Root cause | Device Design |
| Action | 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 be |
| Quantity | 1147 |
| Distribution | US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200849 | Tempus LS - Manual Remote Diagnostic Technologies, Ltd. A Philips Company, Jul 24, 2020 |