Recall Z-0262-2016— Philips Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-11-19, terminated 2018-02-20. It names 5 FDA 510(k) clearances: K062233, K061707, K051134 and 2 more. Product: Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 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 the order of a physician. Reason: 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..
- Recalling firm
- Philips Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-19
- Terminated
- 2018-02-20
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
5 on FDA's record- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K061707 — HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
- K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
- K040404 — HEARTSTART MRX, MODEL M3535A
- K031187 — HEARTSTART MRX, MODEL M3535A
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 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 the order of a physician
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.