Philips North America, LLC recalls HeartStart XL+ Defibrillator/Monitor, Model 861290
- Recall date
- October 3, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0608-2020
- FDA classification
- Class II
- Brand / firm
- Philips North America, LLC
- Sold / distributed
- US Nationwide
Why it was recalled
Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
HeartStart XL+ Defibrillator/Monitor, Model 861290
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