| Class 2 Device Recall Philips Healthcare | |
Date Initiated by Firm | December 10, 2013 |
Date Posted | December 24, 2013 |
Recall Status1 |
Terminated 3 on April 18, 2017 |
Recall Number | Z-0570-2014 |
Recall Event ID |
67046 |
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 MA 01810-1032
|
For Additional Information Contact | 978-687-1501 |
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 | 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 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
|
|
|
|