HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termi
FDA device recall Z-1120-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source
- Action taken
- The firm, Philips Healthcare, sent an "URGENT- Medical Device Correction" letter dated February 2014 and issued a Field Safety Notice on February 18/ 2014 to its customers. The letter and field safety notice informs customers of the issue, 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. Philips will replace the affected batteries free of charge. Philips instructed customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See the HeartStart MRx Instructions for Use for the minimum recommended separation distance between RF communications equipment and the HeartStart MRx. The condition can be avoided by operating the device on AC or external DC power or by the following actions when operating on battery. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 43,792 batteries
- Distribution
- Worldwide Distribution: US (nationwide) and Internationally to: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGUIM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, CONGO
- Date initiated
- 2014-02-18
- 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 |
|---|---|---|
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |