| Class 2 Device Recall Philips Healthcare | |
Date Initiated by Firm | June 20, 2012 |
Date Posted | July 11, 2012 |
Recall Status1 |
Terminated 3 on August 14, 2013 |
Recall Number | Z-1986-2012 |
Recall Event ID |
62342 |
510(K)Number | K051134 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product | Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03
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 |
Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952 |
Recalling Firm/ Manufacturer |
Philips Healthcare Inc. 3000 Minuteman Road Andover MA 01810
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For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Philips Healthcare issued an Urgent Voluntary Medical Device Correction letter on June 20, 2012, to all affected customers. The Notification informs customers of the issue, identifies details (including models and software versions applicable) of units affected, instructions on actions to take while awaiting the correction, and identifies what action Philips plans to eliminate or remedy the issue
A Philips Healthcare representative will contact customers to arrange for the updated R.03.03 software installation in all the affected devices.
For questions customers were advised to call 1-800-722-9377.
For questions regarding this recall call 978-687-1501. |
Quantity in Commerce | 35 units |
Distribution | Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MKJ
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