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U.S. Department of Health and Human Services

Class 2 Device Recall HEARTSTART MRX, MODEL M3535A

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 Class 2 Device Recall HEARTSTART MRX, MODEL M3535Asee related information
Date Initiated by FirmAugust 21, 2009
Date PostedNovember 09, 2009
Recall Status1 Terminated 3 on April 25, 2017
Recall NumberZ-0003-2010
Recall Event ID 52990
510(K)NumberK031187 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductHeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Code Information Serial numbers within the following range. US00533518 through US00535118.
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information ContactSAME
978-687-1501
Manufacturer Reason
for Recall		incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power
FDA Determined
Cause 2		Process change control
ActionPhilips Healthcare issued a Urgent Voluntary Medical Device Correction Notification on August 21, 2009 advising users of the problem and Customers are asked to follow the "Action to be taken by customer/user" section of the Urgent Voluntary Medical Device Correction Notification. In this section, customers are given the instructions to correct their devices. For further information or support concerning this issue, please contact Philips representative at 1-800-722-9377.
Quantity in Commerce1,523 units
DistributionNationwide Canada Australia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MKJ
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