Recall Z-0348-2018— Philips Electronics North America Corporation

Name: FDA recall Z-0348-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-17

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-07-17, terminated 2018-07-12. It names 5 FDA 510(k) clearances: K062233, K061707, K051134 and 2 more. Product: ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014. Reason: Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-07-17
Terminated: 2018-07-12
Firm location: Andover, MA, United States

510(k) clearances named in this recall

5 on FDA's record

K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATORPhilips Medical Systems North America, Inc.·cleared 2006-11-22
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 - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014

Reason for recall

Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.

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