Recall Z-2588-2017 ยท OSP Uterine Electromyographic Monitor
MONICA HEALTHCARE LTD
Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if
| Date | May 25, 2017 (initiated Apr 28, 2017) |
| Status | Terminated |
| Reason | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. |
| Root cause | Nonconforming Material/Component |
| Action | The recall strategy outlined below addresses the depth of the recall, plan for public notification, and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction customer letter (attached) to customers with affected units. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to correct all affected Products at no cost to the customer. The plan for public notification is to contact all customers with affected systems by m |
| Quantity | 4,110 (4,106 US; 4 OUS) |
| Distribution | The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140862 | MONICA NOVII WIRELESS PATCH SYSTEM Monica Healthcare, Ltd., Aug 27, 2014 |