FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: 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.
- Recall number
- Z-1108-2014
- Recalling firm
- Philips Medical Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-02-18
- Posted
- 2014-02-26
- Terminated
- 2015-11-12
- Reason
- Wireless Link may be unable to transmit data when configured for a specific data flow.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K051134"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28