Z-1789-2014 Class II Terminated
FDA device recall Z-1789-2014 was initiated by Childrens Medical Ventures on April 29, 2014 and is designated Class II. 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 p… The recall status is terminated (terminated April 6, 2015). Affected quantity: 112.
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2014
- Initiation Date
- April 29, 2014
- Termination Date
- April 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112
Product Description
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.
Distribution Pattern
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.
Code Information
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