Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting
FDA device recall Z-2328-2015 · posted 2015-08-04 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- Multiple software and hardware issues with device that can affect its function.
- Action taken
- On June 29, 2015, Philips sent an Urgent Medical Device Correction notification/Field Safety Notice (FSN) to inform customers of the issue. The FSN identifies details of the units affected, gives instructions on actions to be taken by the customer, and identifies what action Philips plans to take to remedy the issue. An upgrade consisting of both software and hardware will be provided free of charge for all units affected by these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades. Philips is asking customers to follow the "Action to be Taken by Customer/User" section of the Urgent Medical Device Correction notification/Field Safety Notice. For questions contact your local Philips representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 13,168 devices
- Distribution
- Worldwide Distribution - US Nationwide including PUERTO RICO, Canada, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BULGARIA, CHILE, CHINA, COLOMBI
- Date initiated
- 2015-06-05
- Date posted
- 2015-08-04
- Date terminated
- 2019-02-25
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES (K110825) | Philips Medical Systems | 2012-02-16 |