HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ recall: Software Issue
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the…
Why was HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.
- Product
- HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the…
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- 4315
- Distribution
- Foreign Only - China
- Recall date
- March 21, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)