Reported Jun 25, 2014 · Terminated

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

Childrens Medical Ventures

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: Childrens Medical Ventures · 191 Wyngate Dr · Monroeville, PA · 15146-3045

Is this the product you have?

  • Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Lot codes and dates
    • 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
Amount recalled
112

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 6, 2015 · Data as of Sep 19, 6:07 PM UTC

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