• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare

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


New Search Back to Search Results
 Class 2 Recall
Philips Healthcare
see related information
Date Posted December 24, 2013
Recall Status1 Open
Recall Number Z-0570-2014
Recall Event ID 67046
Premarket Notification
510(K) Number
K051134 
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement 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. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.
Code Information Software versions: F.02, R.02, 9.xx or any earlier versions Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade
Recalling Firm/
Manufacturer
Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover, Massachusetts 01810-1032
Manufacturer Reason
for Recall
MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips Healthcare issued an Customer Information letter dated February 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer with the addendum to the Instructions for Use. If you have a ? in the parameter block and no CO2 waveform on the display, the waveform source is invalid. If invalid, check patient, confirm airway status and examine the FilterLine to make sure it is connected to the device and not kinked or pinched. For more information on the EtCO2 Option see Monitoring Carbon Dioxide chapter in the HeartStart MRx Instructions for Use. Should you have any questions or concerns, please contact your local Philips representative at 1-800-722-9377.
Quantity in Commerce 18,529 units
Distribution US Nationwide and OUS.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
-
-