FDA Device recall Z-0861-2022
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 by Remote Diagnostic Technologies, citing distribution of Defibrillators that are not approved or cleared for distribution US Market.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0861-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-28 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Remote Diagnostic Technologies |
| Distribution | US |
Product
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Reason
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Identifiers
| code_info | Device Serial Numbers 7021.002073 and 7021.002074 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0861-2022%22
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