# K110825: Philips Heartstart XL+, Philips Heartstart External Paddles, Philips Multifunction Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Feb 16, 2012 after 330 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HeartStart FR2: named in the summary without a submission number
- (no number) HeartStart XL: named in the summary without a submission number
- (no number) HeartStart MRx: named in the summary without a submission number

## Most influential descendants
- K133659: Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide Monitoring (2015), 1 descendant of its own
- K200849: Tempus LS - Manual (2020), 0 descendants of its own

## Recalls of this device
- Oct 16, 2019 · Class II · Z-0498-2020: The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device 
- Oct 3, 2019 · Class II · Z-0608-2020: Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attem
- Feb 7, 2018 · Class III · Z-0978-2018: 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 
- Jun 5, 2015 · Class II · Z-2328-2015: Multiple software and hardware issues with device that can affect its function.
- Apr 2, 2014 · Class II · Z-1438-2014: Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
- Mar 31, 2014 · Class II · Z-1439-2014: A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
- Jan 24, 2014 · Class II · Z-1107-2014: HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling
- Jan 28, 2013 · Class II · Z-0871-2013: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use

## Indications for use
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. The HeartStart XL+ is a defibrillator monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician. AED Mode is used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless. Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation (cardioversion) is indicated for termination of atrial fibrillation. The pacing option is indicated for treating patients with symptomatic bradycardia. The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level. The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure. The ECG monitoring option is indicated to be used for monitoring, alarming, and recording of the patient's heart rate and morphology.

Source page: https://510kreport.com/device/K110825
Methodology: https://510kreport.com/methodology