Reported Mar 5, 2014 · Terminated
M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of…
Philips Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- 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.
- Lot codes and dates
183 of 183 codes
US00100253US00547494US00565643US00567331US00100950US00558361US00565651US00567332US00204282US00560173US00565652US00567333US00210992US00560174US00565653US00567334US00210993US00560175US00565655US00567335US00210994US00560176US00565656US00567336US00210995US00560177US00565657US00567337US00210996US00560178US00565658US00567338US00210997US00561068US00565660US00567339US00210998US00561724US00565661US00567340US00210999US00563602US00565662US00567341US00211000US00563603US00565663US00567720US00211001US00563606US00565664US00567721US00212264US00563607US00565665US00567722US00212265US00565069US00565666US00567723
- Amount recalled
- 220 devices
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Wireless Link may be unable to transmit data when configured for a specific data flow.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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