Recall Z-1633-2020— Physio-Control, Inc.

Name: FDA recall Z-1633-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-20

Class II · Terminated

Class II FDA medical device recall by Physio-Control, Inc., initiated 2020-03-20, terminated 2024-01-25. It names 4 FDA 510(k) clearances: K052057, K012428, K983393 and 1 more. Product: LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED 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 it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.. Reason: Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment.

Recalling firm: Physio-Control, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-20
Terminated: 2024-01-25
Firm location: Redmond, WA, United States

510(k) clearances named in this recall

4 on FDA's record

K052057 — LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORMedtronic Emergency Response Systems, Inc.·cleared 2006-02-17
K012428 — MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORMedtronic Physio-Control Corp.·cleared 2001-09-28
K983393 — LIFEPAK 500 BIPHASICPhysio-Control Corp.·cleared 1999-05-05
K955854 — LIFEPAK 500Physio-Control Corp.·cleared 1996-11-04

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 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED 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 it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.

Reason for recall

Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment

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