—#162388

Product

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 sent on to a central network, if connected.

FDA product code: OSP — Uterine Electromyographic Monitor
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K140862
Affected lot / code info: Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 System passes the Novii function TEST, you may continue to use Monica Novii System without any further action. 5. Complete the attached fax back form (page 4&5) for all Monica Novii System as soon as you have completed the screw replacement. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide - US Nationwide Distribution.

Timeline

Recall initiated: 2017-12-15
Posted by FDA: 2018-03-14
Terminated: 2020-04-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162388. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.