Recall Z-1257-2017— Physio-Control, Inc.

Name: FDA recall Z-1257-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Class I · Terminated

Class I FDA medical device recall by Physio-Control, Inc., initiated 2017-01-13, terminated 2019-08-22. It names one FDA 510(k) clearance: K122600. Product: The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.. Reason: The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage..

Recalling firm: Physio-Control, Inc.
Classification: Class I
Status: Terminated
Initiated: 2017-01-13
Terminated: 2019-08-22
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K122600 — LIFEPAK 1000 DEFIBRILLATORPhysio-Control, Inc.·cleared 2012-10-11

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

The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.

Reason for recall

The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

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