Recall Z-1789-2014 ยท NPF Monitor, Apnea, Home Use
Childrens Medical Ventures
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
| Date | Jun 13, 2014 (initiated Apr 29, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| 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 furth |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061256 | SMARTMONITOR 2PS Respironics, Inc., Aug 2, 2006 |