Automated External Defibrillator - HeartStart MRx recall: Contamination
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Why was Automated External Defibrillator - HeartStart MRx recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483
- Product
- Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
- Recalling firm
- Philips Electronics North America Corporation
- Quantity
- 20 units ( 18 domestic, 2 foreign)
- Distribution
- 20 units affected. 18 domestic, 2 foreign.
- Recall date
- December 27, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)