Philips/Children's Medical Ventures Smart Monitor 2… recallZ-1789-2014 · Childrens Medical Ventures · initiated Apr 29, 2014
Class II Terminated All recalls posted in June 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Childrens Medical Ventures or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1789-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 29, 2014
- Posted by the FDA
- Jun 13, 2014
- Recalling firm
- Childrens Medical Ventures
- Quantity
- 112
- Product code
- NPF
- FDA submissions
- K061256
- 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 description
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
4 devices cleared under K061256 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SmartMonitor 2PS w/ Modem 1014557Circadiance, LLC · Monitor, Apnea, Home Use18 reports
- SmartMonitor 2PSL w/ Modem 1028970Circadiance, LLC · Monitor, Apnea, Home Use3 reports
- SmartMonitor 2PS Hospital Alarm 1030271Circadiance, LLC · Monitor, Apnea, Home Use1 report
- SmartMonitor 2PSL Hospital Alarm w/ Modem 1038140Circadiance, LLC · Oximeter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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