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.
FDA Recall Z-1108-2014 · Posted 2014-02-26
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Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2014-02-18
Date Terminated2015-11-12
Product Quantity220 devices
Reason for Recall
Wireless Link may be unable to transmit data when configured for a specific data flow.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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