Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting
FDA device recall Z-1107-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling
- Action taken
- Philips Healthcare issued a Customer Information Letter on January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers with an IFU Addendum titled: HeartStart XL+ Instructions for Use Addendum. Philips has revised the labeling in the addendum to specify the battery charge time with device turned off and AC power connected. The revised specification is: With temperature at 25C (77F), less than 3 hours to 100% capacity; less than 2 hours to 80% capacity. Please contact your local Philips Representative at 1-800-722-9377.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 7157 units
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMBIA
- Date initiated
- 2014-01-24
- Date posted
- 2014-02-26
- Date terminated
- 2020-09-03
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES (K110825) | Philips Medical Systems | 2012-02-16 |