Recall Z-0817-2020— Physio-Control, Inc.

Name: FDA recall Z-0817-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Class II · Terminated

Class II FDA medical device recall by Physio-Control, Inc., initiated 2019-12-20, terminated 2022-10-04. It names one FDA 510(k) clearance: K142430. Product: LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits. Reason: Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button..

Recalling firm: Physio-Control, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-20
Terminated: 2022-10-04
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K142430 — LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.·cleared 2014-12-19

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 15 MONITOR/DEFIBRILLATOR service kits

Reason for recall

Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.

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