Philips Tempus LS-Manual Defibrillator — Class II medical device recall Z-2028-2024
Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2024-06-12, distributed nationwide. Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may
| Recall number | Z-2028-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Farnborough, N/A, United Kingdom |
| Recall initiated | 2024-05-09 |
| Classified | 2024-06-06 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,745 |
| Model numbers | 00-3020 |
Product
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2028-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.