Philips/Children's Medical Ventures Smart Monitor 2 Professional… — Class II medical device recall Z-1789-2014
Terminated recall by Childrens Medical Ventures, reported 2014-06-25, distributed in AZ, FL, IN, KS, MA, MI, MN, NV…. The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes
| Recall number | Z-1789-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Childrens Medical Ventures, Monroeville, PA, United States |
| Recall initiated | 2014-04-29 |
| Classified | 2014-06-13 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2015-04-06 |
| Distributed | AZ, FL, IN, KS, MA, MI, MN, NV, SC, TX, UT, VA, WI, WV |
| Countries outside the US | AU, BE, CA |
| Quantity | 112 |
| UPC / GTIN / UDI-DI | 00989805604531 |
Product
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1789-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.