Recall Z-1082-2013— Physio Control, Inc.

Name: FDA recall Z-1082-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-08

Class II · Terminated

Class II FDA medical device recall by Physio Control, Inc., initiated 2013-02-08, terminated 2015-11-05. It names one FDA 510(k) clearance: K011144. Product: The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.. Reason: LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue..

Recalling firm: Physio Control, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-08
Terminated: 2015-11-05
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K011144 — LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATORMedtronic Physio-Control Corp.·cleared 2001-12-03

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 CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators.

Reason for recall

LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.

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