FDA Device recall Z-2028-2024
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual by Remote Diagnostic Technologies, citing simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortion….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2028-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-09 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Remote Diagnostic Technologies |
| Distribution | US |
Product
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Reason
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
Identifiers
| code_info | 00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2028-2024%22
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