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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm November 19, 2014
Date Posted November 13, 2015
Recall Status1 Terminated 3 on September 12, 2017
Recall Number Z-0273-2016
Recall Event ID 72477
510(K)Number K031187  K040404  K051134  K061707  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
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+
Code Information All Philips M1783A and M5526A sync cables are affected by this issue. The model number is printed on the outside of the cable, near the end with the ¿ inch phone plug.
Recalling Firm/
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action Philips sent an Urgent - Field Safety Notice dated November, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips plans to take to remedy the issue. A replacement cable will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. 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: Prior to receiving a replacement sync cable, you can continue to use affected sync cables, provided that they are only used to connect the ECG Out jack on the monitor/defibrillator to the ECG (input) port on a bedside monitor. The issues described in this letter do not impact this application of the sync cable. Affected sync cables should not be used to connect the ECG Out jack of a bedside monitor to the ECG (input) port on the monitor/defibrillator. For further questions please call (800) 722-9377.
Quantity in Commerce 18,604
Distribution Worldwide Distribution - US (nationwide) and to the countries of : Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ethiopia, Finland, France, Gabon, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Lebanon, Macau, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Yemen.
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, INC.