Recall Z-1923-2019 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
| Date | Jul 5, 2019 (initiated Jun 7, 2019) |
| Status | Terminated |
| Reason | The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery. |
| Root cause | Process control |
| Action | On June 7, 2019, the firm mailed Urgent Medical Device Correction letters to customers, informing them that the AC Power Module may fail, which may lead to an interruption of monitoring or a delay in the delivery of a shock or pacing therapy. A failed AC Power Module also will not charge the battery. Customers were asked to take the following actions: 1. Per the Instructions for Use (IFU), the HeartStart MRx Monitor/Defibrillator can be powered by either a Lithium Ion battery or AC mains power (using the M3539A AC Power Module). However, a charged battery should always be installed in the de |
| Quantity | 97,794 Units |
| Distribution | Nationwide domestic distribution. Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063375 | HEARTSTART MRX, MODELS M3535A OR M3536A Philips Medical Systems, Jan 11, 2007 |