Recall Z-1189-2013 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Healthcare Inc.
HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
| Date | Apr 29, 2013 (initiated Apr 8, 2013) |
| Status | Terminated |
| Reason | Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. |
| Root cause | Software design |
| Action | The firm, Philips Healthcare, sent an "Field Safety Notice-URGENT - MEDICAL DEVICE RECALL" letter dated April 2013 to its customers. The letter describes the product, problem and actions to be taken. In addition, letter provides instructions for using the MRx prior to receiving the software upgrade and informs the customer that Philips is initiating a correction consisting of a software upgrade for all units affected. The customers were instructed to follow the "ACTION TO BE TAKEN BY CUSTOMER/USER" section of the Field Safety Notice; send a copy of the attached package including customer le |
| Quantity | 64972 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Cze |
| 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 |