Philips recalls HeartStart XL+ Defibrillators made before Sept 2017 that need software update A.03 for operational safety. Update to prevent incomplete device readiness checks.
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.
Philips is recalling HeartStart XL+ defibrillators made before September 2017 that require a software update to ensure proper device readiness checks. This update addresses potential incomplete operational checks that could affect safety during medical use.
The device may not properly check readiness if software isn't updated to version A.03. This could lead to incomplete operational checks during medical use, potentially affecting safety. The hazard is specific to the software version and not a physical defect.
Healthcare professionals using the HeartStart XL+ defibrillator in hospital settings. Medical personnel trained in basic or advanced life support are most at risk if the device hasn't been updated.
Check for HeartStart XL+ defibrillators made before September 2017. The device must have been manufactured without the F5N86100172 update if affected.
Download and install software version A.03 to ensure complete operational checks and device readiness.
Yes, if your device was made before September 2017 and hasn't been updated to software version A.03.
The device may not properly check readiness, potentially affecting safety during medical use.
No, the HeartStart XL+ is intended for hospital use by qualified medical personnel only.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0978-2018 — Philips Philips Hello, I own a Philips that is covered by recall Z-0978-2018 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.