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

FDA device recall Z-1789-2014 · posted 2014-06-13 · Terminated

Recall details

Recalling firm

Childrens Medical Ventures

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.

Action taken

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

Status

Terminated

Product code

NPF

Quantity affected

112

Distribution

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.

Date initiated

2014-04-29

Date posted

2014-06-13

Date terminated

2015-04-06

Location

Monroeville, PA

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