Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart MRx

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall HeartStart MRxsee related information
Date Initiated by FirmApril 14, 2016
Create DateJune 02, 2016
Recall Status1 Terminated 3 on March 27, 2019
Recall NumberZ-1612-2016
Recall Event ID 73825
510(K)NumberK031187 K040404 K051134 K061707 K062233 K063375 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductHeartStart MRx Monitor/Defibrillator The HeartStart MRx 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 in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Code Information US00586611, US00589878, US00594232, US00588464, US00591080, US00594779, US00588657, US00592182, US00594913, US00589391, US00593861, US00595298, US00589472, US00594092, US00595443, US00589851, US00594168
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
FDA Determined
Cause 2		Employee error
ActionPhilips Healthcare sent an Urgent Medical Device Correction letter dated April 2016, on April 14, 2016, to all affected customers. The letter informed customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a replacement MRx unit, free of charge, for all units affected by this issue. When the replacement unit arrives, please use the return shipping label and packaging provided with the replacement MRx unit to return the affected unit to Philips. 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: You can continue to use your MRx prior to receiving a replacement unit. But, if you observe a red X in the Ready for Use (RFU) indicator, you should follow the troubleshooting instructions in the MRx IFU. Customers with questions were instructed to contact their local Philips representative or call 1-800-722-9377.
Quantity in Commerce17
DistributionWorldwide Distribution - US including OH, CA, NC and Internationally to China, Iraq, Japan, and Korea.
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
510(K)s with Product Code = MKJ
510(K)s with Product Code = MKJ
-
-