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U.S. Department of Health and Human Services

Class 2 Device Recall ECG Out Cable

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  Class 2 Device Recall ECG Out Cable see related information
Date Initiated by Firm July 17, 2017
Create Date January 14, 2018
Recall Status1 Terminated 3 on July 12, 2018
Recall Number Z-0348-2018
Recall Event ID 78702
510(K)Number K031187  K040404  K051134  K061707  K062233  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
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
Code Information 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
Recalling Firm/
Manufacturer
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Tom Fallon
978-659-3000
Manufacturer 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+.
FDA Determined
Cause 2
Device Design
Action Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Customers should remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the attached reply form, which should be returned to Philips. Customers should retain a copy of the reply form. The customer should follow the Instructions for Use that describe the recommended approach for performing cardioversion with the XL+ and MRx monitor/defibrillators. The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy; this is the preferred source of an ECG waveform for synchronization.
Quantity in Commerce 15811
Distribution 1067 US customers 163 Canada, 917 International
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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