Recall Z-0322-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
HeartStart MRx Defibrillator/Monitor Models: 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. It must be used by or on th
| Date | Nov 8, 2010 (initiated Jul 16, 2010) |
| Status | Terminated |
| Reason | Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on: " Default ECG Lead Behavior " Synchronized Cardioversion using External Paddles |
| Root cause | Labeling design |
| Action | Philips issued an Urgent Voluntary Medical Device Correction notification/Field Safety Notice and an Instructions for Use Addendum on July 20, 2010, to affected customers. The Notice identified the product, the problem, and the action customers should take. In the USA, the notification sent to all affected customers via UPS and confirmation of delivery would be tracked. Outside the USA, Philips representatives in the affected geographies would manage their mailings locally. Customers were instructed to review the HeartStart MRx Instructions for Use addendum and keep a copy with their equipm |
| Quantity | 41,119 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: CANADA AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULGARIA CHILE CHINA COLOMBIA CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA FINLAND FRANCE GERMANY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051137 | TECHDEVICE OCCLUSION BALLOON CATHETER Techdevice Corporation, Feb 24, 2006 |