Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx
FDA device recall Z-0262-2016 · posted 2015-11-10 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case.
- Action taken
- Philips Heatlhcare issued on November 19, 2014, an Urgent Medical Device Correction notification/Field Safety Notice. 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. A software upgrade will be provided free of charge for all units affected by one or more of these issues. 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 Safety Notice: You can continue to use your MRx prior to receiving the hardware upgrade provided you follow the steps given. For questions regarding this recall call 978-687-1501 Customers with questions were instructed to contact their local Philips representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 27,918 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA (local name
- Date initiated
- 2014-11-19
- Date posted
- 2015-11-10
- Date terminated
- 2018-02-20
- Location
- Andover, MA
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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 |