HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M353
FDA device recall Z-1417-2017 · posted 2017-03-24 · Terminated
Recall details
- Recalling firm
- Philips North America, LLC
- Reason for recall
- HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
- Action taken
- Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice. on 2/24/17. The Urgent Medical Device Correction notification/ Field Safety Notice informs customers of 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. Action (1) Philips is voluntarily initiating this correction and is providing Instructions for Use (IFU) Addendum titled, HeartStart MRx Battery Connector Pins for all customers with affected units. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Philips is asking the customer when inspecting the device, to inspect the HeartStart MRx battery compartment connections. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue. Action (2) Philips is voluntarily initiating this correction and is providing measures to prevent, or methods to allow the user to correct, the abnormal device behavior related to charging and pacing after disconnecting the device from AC mains.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 97,794 total ( 47,362 US and 50,429 OUS)
- Distribution
- Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA
- Date initiated
- 2017-02-24
- Date posted
- 2017-03-24
- Date terminated
- 2020-04-17
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX MONITOR/DEFIBRILLATOR (K062233) | Philips Medical Systems North America, Inc. | 2006-11-22 |
| HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS (K061707) | Philips Medical Systems | 2006-08-11 |
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |
| HEARTSTART MRX, MODEL M3535A (K040404) | Philips Medical Systems, Inc. | 2004-05-04 |
| HEARTSTART MRX, MODEL M3535A (K031187) | Philips Medical Systems | 2003-08-27 |