GE Healthcare recalls Monica Novii Wireless Patch System units from 2016-2017 due to risk of swapped fetal and maternal heart rate readings if cables are disconnected and reconnected incorrectly.
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).
GE Healthcare is recalling Monica Novii Wireless Patch Systems made between January 2016 and November 2017. If users disconnect and reconnect the system cables incorrectly, the fetal and maternal heart rate readings could be swapped, potentially causing misdiagnosis during pregnancy monitoring.
If the cables are removed by a user and then reconnected incorrectly, the system may display swapped fetal heart rate and maternal heart rate signals. This could lead to misdiagnosis of the pregnancy's health status if the monitor is used for clinical purposes.
Pregnant individuals using the Monica Novii Wireless Patch System for fetal monitoring are most at risk. The recall affects all units distributed from January 2016 through November 2017.
Check for the model number 107-PT-020 on the system. The product was distributed between January 2016 and November 2017.
Ensure the cables are connected properly to avoid swapped heart rate readings.
The recall is due to the risk of swapped fetal and maternal heart rate readings if the cables are disconnected and reconnected incorrectly.
Model number 107-PT-020, distributed from January 2016 through November 2017.
Check for model number 107-PT-020 on the system, as these units were distributed between January 2016 and November 2017.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1292-2018 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1292-2018 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.
