Z-1789-2014Class II

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

Name: Z-1789-2014 Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor
Creator: Childrens Medical Ventures
Published: 2014-04-29
License: https://open.fda.gov/license/

Childrens Medical Ventures, LLC / initiated 2014-04-29 / Terminated / root cause: design

FDA source

Childrens Medical Ventures began a recall of Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor on 2014-04-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1789-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-29
Posted: 2014-06-13
Terminated: 2015-04-06
Recalling firm: Childrens Medical Ventures, LLC
Product: Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Product code: NPF Monitor, Apnea, Home Use
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.
Root cause tag: design
FDA 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 further questions please call (412) 380-8881. Philips apologizes for any inconveniences caused by this problem.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1789-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1789-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-13

Product code NPF

K061256Class IISmartmonitor 2PsRespironics, Inc. / cleared 2006-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)