Recall Z-0557-2025 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Remote Diagnostic Technologies Ltd.
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
| Date | Nov 26, 2024 (initiated Oct 28, 2024) |
| Status | Open, Classified |
| Reason | Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number. |
| Root cause | Labeling Change Control |
| Action | On 10/28/2024, Philips sent an "URGENT Medical Device Correction" Letter via Certified Mail to customers informing them that SCHILLER AG, the manufacturer of the Tempus LS Manual Defibrillator, informed Philips that the incorrect labels were supplied with the service kit (kits 3, 6 and 8). The affected labels can be identified by the wrong device name (TEMPUS LS instead of TEMPUS LS MANUAL), the wrong CAT number (00-3010 instead of 00-3020) and the additional CE marking. SCHILLER AG initiated a correction on 10/07/2024. Customers are instructed to: Share this recall notice with those who ne |
| Distribution | U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA. |
| 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 |