FDA Medical Device Recalls (openFDA)
Philips North America, LLC: HeartStart XL+ Defibrillator/Monitor, Model 861290
- Recall number
- Z-0498-2020
- Recalling firm
- Philips North America, LLC
- Product
- HeartStart XL+ Defibrillator/Monitor, Model 861290
- Status
- Terminated
- Initiated
- 2019-10-16
- Posted
- 2019-11-19
- Terminated
- 2023-11-29
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 23,749 Units
- Distribution
- US Nationwide
- Lot, serial or model codes
- All units manufactured prior to 1 May 2017.
- 510(k) numbers
- ["K110825"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28