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Z-0978-2018 Class III Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

FDA device recall Z-0978-2018 was initiated by Philips Electronics North America Corporation on Feb 7, 2018 and is designated Class III. Reason for recall: 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… The recall status is terminated (terminated Feb 7, 2020). Affected quantity: 4315.

Recall Details

Product Type: Devices
Report Date: Mar 21, 2018
Initiation Date: Feb 7, 2018
Termination Date: Feb 7, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4315

Product Description

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 for Recall

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.

Distribution Pattern

Foreign Only - China

Code Information

HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0978-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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