FDA Device recall Z-0978-2018
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in…
- FDA Device
- Class III
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class III recall of HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in… by Philips Electronics North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0978-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-02-07 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
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.
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.
Identifiers
| code_info | HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0978-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.