Recall Z-1090-2014 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation
| Date | Feb 25, 2014 (initiated Feb 18, 2014) |
| Status | Terminated |
| Reason | A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD), which can disrupt ECG and SpO2 functionality leading to an inability to perform. |
| Root cause | Device Design |
| Action | The firm, Philips, sent an "URGENT - Medical Device Correction" letter dated February, 2014 with an attached Field Safety Notice to each known affected customer on 2/18/14. The letter describes 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 customers were instructed to continue to use your MRx prior to receiving the hardware upgrade; if a failure has been detected that may disable some ECG and SpO2 functionality during patient care, treat your patient per |
| Quantity | 39,128 |
| Distribution | Worldwide Distribution: US (Nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and Internationally to: Cana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051134 | HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A Philips Medical Systems, Sep 8, 2005 |