Recall Z-1789-2014— Childrens Medical Ventures
Class II · Terminated
Class II FDA medical device recall by Childrens Medical Ventures, initiated 2014-04-29, terminated 2015-04-06. It names one FDA 510(k) clearance: K061256. 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..
- Recalling firm
- Childrens Medical Ventures
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-29
- Terminated
- 2015-04-06
- Firm location
- Monroeville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.