Recall Z-1773-2013— Physio Control, Inc.

Name: FDA recall Z-1773-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-12

Class II · Terminated

Class II FDA medical device recall by Physio Control, Inc., initiated 2013-06-12, terminated 2013-09-19. It names one FDA 510(k) clearance: K052057. Product: The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.. Reason: The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable..

Recalling firm: Physio Control, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-12
Terminated: 2013-09-19
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K052057 — LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORMedtronic Emergency Response Systems, Inc.·cleared 2006-02-17

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 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.

Reason for recall

The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.

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