HeartStart XL+ Defibrillator/Monitor, Model 861290

FDA device recall Z-0498-2020 · posted 2019-11-19 · Terminated

Recall details

Recalling firm

Philips North America, LLC

Reason for recall

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.

Action taken

On October 16, 2019, Philips Healthcare issued Urgent Medical Device Correction notices to U.S. customers via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Actions to be taken by the customer: 1) The device is safe to use and can remain in service if it does not exhibit any of these behaviors described in this Notice. 2) Continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure during use. 3) If you identify a device that exhibit any of these behaviors; please remove it from service and contact Philips to request service. Philips will contact you to arrange for repair of your unit once parts are available. Philips will install a replacement switch in affected devices at no charge to the customer. If you need further information or support concerning this notification, please contact your local Philips representative.

Root cause

Process control

Status

Terminated

Product code

MKJ

Quantity affected

23,749 Units

Distribution

US Nationwide

Date initiated

2019-10-16

Date posted

2019-11-19

Date terminated

2023-11-29

Location

Andover, MA

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