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Class 2 Device Recall HeartStart MRx Monitor/Defribillator |
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Date Initiated by Firm |
February 18, 2014 |
Date Posted |
February 26, 2014 |
Recall Status1 |
Terminated 3 on November 12, 2015 |
Recall Number |
Z-1108-2014 |
Recall Event ID |
67481 |
510(K)Number |
K051134
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Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product |
M3536A HeartStart MRx with Wireless Link Upgrade (861289)
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 |
US00100253, US00547494, US00565643, US00567331, US00100950, US00558361, US00565651, US00567332, US00204282, US00560173, US00565652, US00567333, US00210992, US00560174,US00565653, US00567334, US00210993, US00560175, US00565655, US00567335, US00210994, US00560176, US00565656, US00567336, US00210995, US00560177, US00565657, US00567337, US00210996, US00560178, US00565658, US00567338, US00210997, US00561068, US00565660, US00567339, US00210998, US00561724, US00565661, US00567340, US00210999, US00563602, US00565662, US00567341, US00211000, US00563603, US00565663, US00567720, US00211001, US00563606, US00565664, US00567721, US00212264, US00563607, US00565665, US00567722, US00212265, US00565069, US00565666, US00567723, US00212266, US00565414, US00566434, US00567724, US00212267, US00565415, US00566564, US00568419, US00212268, US00565416, US00567302, US00568656, US00322574, US00565417, US00567303, US00568703, US00322575, US00565418, US00567304, US00568704 US00322876, US00565419, US00567305, US00568705, US00322877, US00565420, US00567306, US00568706, US00323134, US00565421, US00567307, US00568748, US00323135, US00565422, US00567308, US00568749, US00323137, US00565423, US00567309, US00568750, US00323138, US00565424, US00567310, US00568751, US00541205, US00565425, US00567311, US00568752, US00541250, US00565427, US00567312, US00568753, US00541254, US00565428, US00567313, US00568754, US00541364, US00565429, US00567314, US00568755, US00541370, US00565430, US00567315, US00568756, US00541397, US00565446, US00567316, US00568757, US00541402, US00565447, US00567317, US00568758, US00541403, US00565448, US00567318, US00568759, US00541405, US00565449, US00567319, US00568760, US00543683, US00565450, US00567320, US00568761, US00543684, US00565451, US00567321, US00568762, US00543860, US00565452, US00567322, US00568763, US00544078, US00565453, US00567323, US00568764, US00544082, US00565454, US00567324, US00568765, US00544089, US00565455, US00567325, US00568766, US00544095, US00565456, US00567326, US00568767, US00547383, US00565457, US00567327, US00568768, US00547456, US00565458, US00567328, US00568769, US00547457, US00565459, US00567329, US00568770, US00547458, US00565642, US00567330, US00568771 |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact |
800-722-9377
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Manufacturer Reason for Recall |
Wireless Link may be unable to transmit data when configured for a specific data flow.
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FDA Determined Cause 2 |
Software design |
Action |
Philips Healthcare sent an Urgent Medical Device Correction letter to all consignees on February 18, 2014. The Letter informs 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.
Philips is initiating a correction to affected devices. Philips will release a new version of Wireless Link software V2.0.0.3 sub1 that corrects the issue. The correction will be provided free of charge to all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the software upgrade.
Customers with questons were instructed to call 1-800-722-9377.
For questions regarding this recall call 800-722-9377. |
Quantity in Commerce |
220 devices |
Distribution |
Worldwide Distribution - USA including AZ, CA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX,and VA and Internationally to Australia, Norway, and Spain. |
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 and Original Applicant = PHILIPS MEDICAL SYSTEMS
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