Recall Z-0278-2018
Philips Electronics North America Corporation · initiated September 28, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Codes / lots: 20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483
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).
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0278-2018
- Initiated
- September 28, 2017
- Terminated
- October 12, 2018
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Quantity
- 20 units ( 18 domestic, 2 foreign)
- Distribution
- 20 units affected. 18 domestic, 2 foreign.
- Recalling firm
- Philips Electronics North America Corporation, Andover, MA