Recall Z-1292-2018— GE Healthcare, LLC

Name: FDA recall Z-1292-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-15

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-12-15, terminated 2020-04-21. It names one FDA 510(k) clearance: K140862. 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.. 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)..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-12-15
Terminated: 2020-04-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K140862 — MONICA NOVII WIRELESS PATCH SYSTEMMonica Healthcare, Ltd.·cleared 2014-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.