The Recall Desk

FDA (Devices) recall action 79464

GE Healthcare, LLC recalled 2 products on 2018-04-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-04-11
Critical
0
Units
2,097

Why these products were 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).

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).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2018-04-11

    GE Healthcare Recalls Monica Novii Wireless Patch System Due to Signal Swap Risk

    GE Healthcare is recalling 1,742 units of the Monica Novii Wireless Patch System because incorrectly reconnected cables may cause fetal and maternal heart rate signals to be displayed swapped.

    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 cabl
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-04-11

    GE Healthcare Recalls Monica IF24 Interface System Due to Signal Swap Risk

    GE Healthcare is recalling 355 Monica IF24 Interface Systems because incorrectly reconnected cables can cause fetal and maternal heart rate signals to be displayed incorrectly.

    Product
    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.
    Category
    Distribution
    0 states