Reported Feb 15, 2017 · Terminated
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in…
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 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
- Lot codes and dates
- LOT NUMBERS OF AFFECTED MODULE
Lot # 1506152015321544and 1551
- SERIAL NUMBERS OF AFFECTED DEVICES
2,584 of 2,584 codes
379309903804656638130282382004673837412138544771385610253856782338577667387634233880557339229417396569033974947739757723397577233990518940007558400076164000823740074226402461864063742840639397408814884111932741441205417345584190807742036185427219824275981943273957439811824412895544143195441433564414339944143438441434814414361644143674441437084414378644143811441438144414389144143894441439844414627844146304441464084414834544148588441486414415089744151007441510844415115144151156
- LOT NUMBERS OF AFFECTED MODULE
- Amount recalled
- 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total
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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