Z-1789-2014 Class II Terminated

Recalled by Childrens Medical Ventures — Monroeville, PA

Recall Details

Product Type
Devices
Report Date
June 25, 2014
Initiation Date
April 29, 2014
Termination Date
April 6, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112

Product Description

Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384