FDA-Device2018-01-17Class I
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
Physio-Control, Inc.
Hazard
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
Sold states
Worldwide Distribution
Affected count
3831 units
Manufactured in
11811 Willows Rd NE, N/A, Redmond, WA, United States
Products
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2018Don't want to check this manually?
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