Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessor

FDA device recall Z-1292-2018 · posted 2018-03-14 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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).

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

OSP

Quantity affected

1742

Distribution

Worldwide - US Nationwide Distribution.

Date initiated

2017-12-15

Date posted

2018-03-14

Date terminated

2020-04-21

Location

Waukesha, WI

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