Reported Jun 3, 2020 · Terminated
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by…
Philips North America, LLC
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 North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips HeartStart
- XL Monitor/Defibrillators Model numberM4735A -
- Product Usageis for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
- Lot codes and dates
- Serial Numbers
130 of 130 codes
US00127349US00127341US00127347US00127355US00127357US00127346US00126134US00126145US00126129US00126130US00126131US00126132US00126133US00126135US00126136US00126137US00126141US00126142US00126144US00126146US00126147US00126148US00126168US00126169US00126171US00126172US00126173US00126174US00126175US00126176US00126177US00126179US00126180US00126181US00126182US00126183US00126184US00126185US00126186US00126187US00127365US00127345US00127353US00127362US00127364US00124799US00124800US00126138US00126139US00126140US00126143US00126380US00126381US00126382US00126383US00127371US00127372US00127318US00127334US00127335
- Serial Numbers
- Amount recalled
- 130 units (US 126; OUS 4)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
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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