Recall Z-0861-2022 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Remote Diagnostic Technologies Ltd.
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
| Date | Jan 28, 2022 |
| Status | Terminated |
| Reason | Distribution of Defibrillators that are not approved or cleared for distribution US Market. |
| Root cause | No Marketing Application |
| Action | On January 31, 2022 , Remote Diagnostic initiated notified customer about the recall device via email. Remote Diagnostic issued a "Urgent Medical Device Recall" notification on February 18, 2022 to affected consignees. In addition, to informing consignees about the recalled product, the Remote Diagnostic asked consignees to take the following actions: 1. Arrangements have been made by Philips SPS (Spare Parts Supply Chain) to have the devices returned to Philips and for the devices to be replaced with the correct model of devices, i.e. Tempus LS-Manual (Part Number 00-3020) 2. If you need a |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of IL and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.