Date Initiated by Firm | February 07, 2018 |
Create Date | March 13, 2018 |
Recall Status1 |
Terminated 3 on February 07, 2020 |
Recall Number | Z-0978-2018 |
Recall Event ID |
79191 |
510(K)Number | K110825 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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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. |
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. |
Recalling Firm/ Manufacturer |
Philips Electronics North America Corporation 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | Gary Gilliam 978-659-3000 |
Manufacturer 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. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Philips is initiating a correction to affected devices. A software upgrade is available free of charge for all units affected by the issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Customers may continue to use XL+ prior to receiving the software upgrade. For further questions, please call (978) 659-3000. |
Quantity in Commerce | 4315 |
Distribution | Foreign Only - China |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MKJ
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