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FDAMay 9, 2024device

Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

remote diagnostic technologiesremoteremote diagnostic

UPCs

07613365002737

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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