Recall Z-0273-2016 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Electronics North America Corporation
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
| Date | Nov 13, 2015 (initiated Nov 19, 2014) |
| Status | Terminated |
| Reason | When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing. |
| Root cause | Device Design |
| Action | Philips sent an Urgent - Field Safety Notice dated November, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips plans to take to remedy the issue. A replacement cable will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the: Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Saf |
| Quantity | 18,604 |
| Distribution | Worldwide Distribution - US (nationwide) and to the countries of : Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ethiopia, Finland, France, Gabon, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Is |
| 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 |