Reported Mar 6, 2019 · Terminated
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute…
Physio-Control Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Product UsageThe LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is 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. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older
- Lot codes and dates
- Serial Numbers
3,259 of 3,259 codes
383447713852339639370585397471924026696640284286402842894028429740758461407675554091843140991313409914524099170040991743409917464099199640995181409952944099532340995420409954214099550840995550409955834099561340995621409956564121640541216406412165664121658141216600412166084121661741216618412166314121663241216636412166504121665541216660412166654121666841216680412166824121673641216743412167674121679541216797412168064121682241216828412168494121685141216854412169174121692541216955
- Serial Numbers
- Amount recalled
- 13,005 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
Using this product could cause serious injury, illness or death — stop using it now.
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