Reported Jun 12, 2024 · Ongoing
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Remote Diagnostic Technologies Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Remote Diagnostic Technologies Ltd. · Farnborough Aerospace Centre · Farnborough, N/A · N/A
Is this the product you have?
- Philips Tempus LS-Manual Defibrillator
- Part Number00-3020 when using Tempus LS-Manual User/Operator Manual
- Lot codes and dates
00-3020: UDI-DI-07613365002737Serial Numbers prior to 7022.002871
- User/Operator Manual Versions41-3007EN-01 and prior
- Amount recalled
- 1745
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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