Reported Feb 15, 2017 · Terminated
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as…
Physio-Control, Inc.
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: Physio-Control, Inc. · 11811 Willows Rd NE · Redmond, WA · 98052-2003
Is this the product you have?
- LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
- Lot codes and dates
- LOT NUMBERS OF AFFECTED MODULELot # 1520 and 1544
- SERIAL NUMBERS OF DEVICES
328778203435689135984435372231103744040137456675and 37913307
- Amount recalled
- 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
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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