FDAClass IINovember 27, 2019

HeartStart XL+ Defibrillator/Monitor recall

HeartStart XL+ Defibrillator/Monitor, Model 861290

Why was HeartStart XL+ Defibrillator/Monitor recalled?

The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.

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 manufactured prior to 1 May 2017.

Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Recalling firm
Philips North America, LLC
Quantity
23,749 Units
Distribution
US Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls