Reported Dec 27, 2017 · Terminated
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Philips Electronics North America Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
- Lot codes and dates
20 units - US00597060US00597964US00598048US00598210US00598784US00599490US00599495US00599508US00599572US00599613US00599615US00599623US00599726US00600362US00600363US00600370US00600422US00600423US00600438US00600483
- Amount recalled
- 20 units ( 18 domestic, 2 foreign)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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