510(k) K110825 ยท MKJ Automated External Defibrillators (Non-Wearable)
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | Mar 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2019 | Philips North America, LLC HeartStart XL+ Defibrillator/Monitor, Model 861290 Terminated |
MKJ | None listed |
| Oct 3, 2019 | Philips North America, LLC HeartStart XL+ Defibrillator/Monitor, Model 861290 Terminated |
MKJ | None listed |
| Feb 7, 2018 | Philips Electronics North America Corporation 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 ba Terminated |
MKJ | None listed |
| Aug 4, 2015 | Philips Electronics North America Corporation Philips HeartStart XL+ Defibrillator/Monitor
Product Usage:
The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qual Terminated |
MKJ | None listed |
| Apr 9, 2014 | Philips Medical Systems, Inc. Philips HeartStart XL+ Defibrillator/Monitor
Model number: 861290, automatic external defibrillator. Terminated |
MKJ | None listed |
| Apr 9, 2014 | Philips Medical Systems, Inc. Philips HeartStart XL+ Defibrillator/Monitor with system
software version B.00.00 or B.00.01 installed
Model: 861290, automatic external defibrillator. Terminated |
MKJ | None listed |
| Feb 26, 2014 | Philips Medical Systems, Inc. Philips HeartStart XL+ Defibrillator/Monitor
Model: 861290
The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and quali Terminated |
MKJ | None listed |
| Feb 21, 2013 | Philips Healthcare Inc. Philips HeartStart XL+ Defibrillator/Monitor
Model number: 861290
The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device a Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.