Recall Z-1293-2018 ยท OSP Uterine Electromyographic Monitor
GE Healthcare, LLC
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fet
| Date | Mar 14, 2018 (initiated Dec 15, 2017) |
| Status | Terminated |
| Reason | if the cables of the Monica IF24 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 | 355 |
| Distribution | Worldwide - US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112163 | MONICA IF24 Monica Healthcare, Aug 30, 2011 |