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Terminated

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

FDA Recall Z-1789-2014 · Posted 2014-06-13

Recall StatusTerminated
Product CodeNPF
Date Initiated2014-04-29
Date Terminated2015-04-06
Product Quantity112

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.

Firm Action

Philips sent an Urgent Medical Device Correction letter dated April 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Customer Information is intended to inform you about: 1.what the problem is and under what circumstances it can occur 2.the actions that you as a customer can take to minimize the effect of the problem 3.the actions planned by Philips to correct the problem. If you need any further information or support concerning this issue, please contact your local Philips representative: For further questions please call (412) 380-8881. Philips apologizes for any inconveniences caused by this problem.

Root Cause

Component design/selection

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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