FDA-Device2014-06-25Class II
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Childrens Medical Ventures
Hazard
The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
Sold states
Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada.
Affected count
112
Manufactured in
191 Wyngate Dr, N/A, Monroeville, PA, United States
Products
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1789-2014Don't want to check this manually?
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