GE Healthcare recalls Monica IF24 Interface System units (model 105-PT-001) sold 2011-2016. If cables are removed and reconnected incorrectly, fetal and maternal heart rate signals may be swapped, potentially causing misdiagnosis during pregnancy monitoring.
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).
GE Healthcare is recalling Monica IF24 Interface Systems made between October 2011 and May 2016. If users remove and reconnect the cables incorrectly, the device may display fetal and maternal heart rates in the wrong order, which could lead to incorrect pregnancy monitoring decisions.
The device displays fetal heart rate (FHR) and maternal heart rate (MHR) signals. If the cables are removed and reconnected incorrectly, the signals may be swapped, showing the wrong heart rates. This could lead to misdiagnosis of the pregnancy condition.
Healthcare professionals using the Monica IF24 Interface System for fetal monitoring during pregnancy. The risk is highest for those who frequently connect/disconnect the device's cables.
Check for model number 105-PT-001 on the device. Units were distributed from October 2011 through May 2016. The device is used with the Monica AN24 for fetal monitoring in clinical settings.
Look for model number 105-PT-001 on the device to confirm if it is recalled.
If the cables are removed and reconnected incorrectly, the device may display fetal and maternal heart rates in the wrong order, which could lead to misdiagnosis during pregnancy monitoring.
The recalled units were distributed from October 2011 through May 2016.
Check for model number 105-PT-001 on the device. The device is used with the Monica AN24 for fetal monitoring in clinical settings.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1293-2018 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1293-2018 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
