FDA Device recall Z-1789-2014
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor
- FDA Device
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor by Childrens Medical Ventures, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1789-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-29 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Childrens Medical Ventures |
| Distribution | AZ, FL, IN, KS, MA, MI, MN, NV, SC, TX, UT, VA, WI, WV |
Product
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
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.
Identifiers
| code_info | 989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1789-2014%22
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