FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
- Recall number
- Z-0978-2018
- Recalling firm
- Philips Electronics North America Corporation
- Product
- HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
- Status
- Terminated
- Initiated
- 2018-02-07
- Posted
- not on file
- Terminated
- 2020-02-07
- Reason
- Update XL device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.
- Root cause
- Labeling mix-ups
- Action
- Philips is initiating a correction to affected devices. A software upgrade is available free of charge for all units affected by the issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Customers may continue to use XL+ prior to receiving the software upgrade. For further questions, please call (978) 659-3000.
- Quantity
- 4315
- Distribution
- Foreign Only - China
- Lot, serial or model codes
- HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.
- 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