Z-1293-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- December 15, 2017
- Termination Date
- April 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 355
Product Description
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 Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
Reason for Recall
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).
Distribution Pattern
Worldwide - US Nationwide Distribution.
Code Information
Model # - 105-PT-001 ( all units distributed from October 2011 - May 2016)