HeartStart XL+ Defibrillator/Monitor recall
HeartStart XL+ Defibrillator/Monitor, Model 861290
Why was HeartStart XL+ Defibrillator/Monitor 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Units, Model number 861290
- Product
- HeartStart XL+ Defibrillator/Monitor, Model 861290
- Recalling firm
- Philips North America, LLC
- Quantity
- 24,738 units
- Distribution
- US Nationwide
- Recall date
- December 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)