Recall Z-0278-2018 ยท MSX System, Network And Communication, Physiological Monitors
Philips Electronics North America Corporation
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
| Date | Sep 28, 2017 |
| Status | Terminated |
| Reason | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram). |
| Root cause | Nonconforming Material/Component |
| Action | The Philips Urgent Medical Device Correction notification/ 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. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue. |
| Quantity | 20 units ( 18 domestic, 2 foreign) |
| Distribution | 20 units affected. 18 domestic, 2 foreign. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031187 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Aug 27, 2003 |
| K040404 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Inc., May 4, 2004 |
| K051134 | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A Philips Medical Systems, Sep 8, 2005 |
| K061707 | HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS Philips Medical Systems, Aug 11, 2006 |
| K062233 | HEARTSTART MRX MONITOR/DEFIBRILLATOR Philips Medical Systems North America, Inc., Nov 22, 2006 |
| K063375 | HEARTSTART MRX, MODELS M3535A OR M3536A Philips Medical Systems, Jan 11, 2007 |