FDA Recall
Terminated
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Recall: Z-0278-2018
·
Initiated September 28, 2017
Recall
- Recall Number
- Z-0278-2018
- Event Number
- 78698
- Firm
- Philips Electronics North America Corporation
- FEI Number
- 1218950
- Product Code
- MSX
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 28, 2017
- Terminated
- October 12, 2018
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
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).
Action
The Philips 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. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue.
Distribution
20 units affected. 18 domestic, 2 foreign.
Quantity
20 units ( 18 domestic, 2 foreign)