Philips HeartStart XL+ Defibrillator Software Update Recall
Philips is recalling 4,315 HeartStart XL+ defibrillators in China to update software that improves device readiness information.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The action is a software update to improve information availability rather than a fix for a critical safety defect.
Plain-English summary
Philips Electronics North America Corporation is recalling 4,315 HeartStart XL+ Defibrillator/Monitor units distributed in China. The recall involves units manufactured before September 2017 that have not been updated and are not affected by a specific prior issue.
The recall is initiated to update the device software to version A.03. This update includes enhancements to operational checks, event logs, and troubleshooting messages, providing users with more complete information regarding device readiness.
The affected devices are intended for use in hospital settings by qualified medical personnel. Users should contact Philips to arrange the software update.
The recalled product
- 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
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 4,315
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- HeartStart XL+ Defibrillator/Monitor
- All Chinese XL manufactured before September
- 2017
- unless the XL+ is affected by F5N86100172
- and has not been updated.
Distribution
Distribution scope not specified by the agency.
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