HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery
FDA device recall Z-1317-2010 · posted 2010-04-09 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on battery.
- Action taken
- An "Urgent Medical Device Correction" letter with a Field Safety Notice was issued on March 4, 2010 to affected customers. The Instructions for Use Addendum/Application Note is included with the communication describing when to replace the unit's 14.8-Volt Lithium Ion Battery (Product #M3538A) Number M3538A in the the Philips HeartStart MRx Monitor/Defibrillator. Should you have any questions or concerns about the Device Correction, please contact your local Philips representative.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 37,674 units
- Distribution
- Worldwide: UNITED STATES, CANADA, AFGHANISTAN, ALBANIA, ,ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM BOSNIA&HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOM
- Date initiated
- 2010-03-04
- Date posted
- 2010-04-09
- Date terminated
- 2017-02-15
- 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 |
|---|---|---|
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |