Recall Z-0278-2018— Philips Electronics North America Corporation
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-09-28, terminated 2018-10-12. It names 6 FDA 510(k) clearances: K063375, K062233, K061707 and 3 more. Product: Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator. Reason: Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram)..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-28
- Terminated
- 2018-10-12
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
6 on FDA's record- K063375 — HEARTSTART MRX, MODELS M3535A OR M3536A
- 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
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Reason for recall
Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).
Data sourced from openFDA. This site is unofficial and independent of the FDA.