Recall Z-0294-2018— Physio-Control, Inc.

Name: FDA recall Z-0294-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-04

Class I · Terminated

Class I FDA medical device recall by Physio-Control, Inc., initiated 2017-12-04, terminated 2024-04-01. It names one FDA 510(k) clearance: K130454. Product: 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.. Reason: 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..

Recalling firm: Physio-Control, Inc.
Classification: Class I
Status: Terminated
Initiated: 2017-12-04
Terminated: 2024-04-01
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.·cleared 2013-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.