Recall Z-0273-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0273-2016
Creator: U.S. Food and Drug Administration
Published: 2014-11-19

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2014-11-19, terminated 2017-09-12. It names 4 FDA 510(k) clearances: K061707, K051134, K040404 and 1 more. Product: ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+. Reason: When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Terminated: 2017-09-12
Firm location: Andover, MA, United States

510(k) clearances named in this recall

4 on FDA's record

K061707 — HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONSPhilips Medical Systems·cleared 2006-08-11
K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536APhilips Medical Systems·cleared 2005-09-08
K040404 — HEARTSTART MRX, MODEL M3535APhilips Medical Systems, Inc.·cleared 2004-05-04
K031187 — HEARTSTART MRX, MODEL M3535APhilips Medical Systems·cleared 2003-08-27

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

ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+

Reason for recall

When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.

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