Recall Z-1292-2018 ยท OSP Uterine Electromyographic Monitor
GE Healthcare, LLC
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: 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 via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and s
| Date | Mar 14, 2018 (initiated Dec 15, 2017) |
| Status | Terminated |
| Reason | if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped). |
| Root cause | Device Design |
| Action | GE Healthcare sent an Urgent Medical Device correction Letter dated December 15, 2017 to their customers. The letter identified the affected product, problem and action to be taken. Customers are instructed to: 1. Follow the attached safety instructions to replace the screws, see attached page 2. 2. Follow the attached safety instructions to perform the Monica Novii function TEST to confirm correct cable connection, see attached page 3. 3. If the Monica Novii System fails the Novii function TEST, contact a GE Healthcare Representative to schedule repair/replacement. 4. If the Monica Novii |
| Quantity | 1742 |
| Distribution | Worldwide - US Nationwide Distribution. |
| 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 |